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Dates:

 9/4/2010 to 9/8/2010

Title:

 9th International ISSX Meeting

Description:

 The Meeting aims to bring together many internationally renowned scientists and young scientists from academia and industry, working on drug/xenobiotic research in diverse fields including basic and clinical pharmacology and therapeutics, toxicology, oncology, endocrinology, physiology, biochemistry, medicinal chemistry, drug discovery and development, molecular and structural biology and genetics, and other related areas.

Location:

 Istanbul, Turkey

E-mail:

 information@issx.org

Link:

 http://www.issx.org/i4a/pages/index.cfm?pageid=3562

Telephone:

 (202) 367-1160

Fax:

 (202) 367-2160

Dates:

 9/5/2010 to 9/6/2010

Title:

 The RPS conference 2010: Supporting patient and professional decision making

Description:

 This brand new event will have a practice and professional focus and will explore patient and professional decision making - how pharmacists, as professionals, can lead the way in maximising the optimal use of medicines, maintaining the best interests of patients and in making the best possible decision during times of workplace stress. This is an opportunity for pharmacists to develop leadership skills and to network and see how such networking has been developed at local levels across the countries.

Location:

 London

E-mail:

 rpsconference@rpsgb.org

Link:

 http://beta.pharmacyplb.com/events-and-courses/the-royal-pharmaceutical-soc

Telephone:

 02075722640

Fax:

Dates:

 9/10/2010 to 9/10/2010

Title:

 Particle Engineering for Orally Inhaled Drug Products

Description:

 This workshop is intended to: Foster and advance the art and science of the pharmaceutical aerosol drug delivery system among Focus Group members and interested parties. Provide and disseminate to its members information relating to matters of scientific and technical interest in the field of aerosol products, aerosol technology, and related processes. Also, foster and encourage a spirit of friendly cooperation among its members and to promote favorable relations between its members and related health professionals.

Location:

 Hilton Garden Inn, Lakewood, NJ

E-mail:

 meetings@aaps.org

Link:

 http://www.aapspharmaceutica.com/meetings/workshops/ParticleEng/index.asp

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 9/11/2010 to 9/12/2010

Title:

 CRS-IPTS Educational Workshop on Vaccine Development

Description:

 This workshop is dedicated to discussing various current issues in vaccine development from the perspective of experts in the field from academia, regulatory, and industry. Co-sponsored by the Controlled Release Society (CRS) and the International Pharmaceutical Technology Symposium (ITPS).

Location:

 Kervansaray Lara Hotel, Antalya, Turkey

E-mail:

Link:

 http://www.controlledrelease.org/main/meetings/2010CRS-ITPS.cfm

Telephone:

Fax:

Dates:

 9/12/2010 to 9/14/2010

Title:

 39th Annual Meeting of the American College of Clinical Pharmacology

Description:

 Various Symposia entitled: Managing the Changing Horizons of Drug Development - Clinical Pharmacologists as Leaders; Pharmacogenomic and Genetic Variation in Different Geographic Regions; Should Nutritional Supplements Be Regulated As Drugs?; Finding the Way Forward: Conducting International Pediatric Clinical Trials; Formulation, Quality, and Safety of Drugs in a Global Marketplace; The Health Benefits of Genomics; Model-based Drug Development: Fantasy or Future?

Location:

 Baltimore Marriott Waterfront, Baltimore, MD

E-mail:

 SUE@ACCP1.org

Link:

 www.ACCP1.org

Telephone:

 315-768-6117

Fax:

 315-768-6119

Dates:

 9/13/2010 to 9/17/2010

Title:

 Thirteenth Annual Land O'Lakes Conference on Drug Metabolism/Applied Pharmacokinetics

Description:

 The purpose of this four-day University of Wisconsin School of Pharmacy conference is to provide an educational forum to discuss the current issues in selecting potential new therapeutic entities for drug development and current issues in drug metabolism, drug transport, pharmacokinetics, and pharmacodynamics. To increase the interactive nature of the conference, the program will be a mixture of lecture, discussion groups, poster session, round table discussions and workshops.

Location:

 Merrimac, WI

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 www.pharmacy.wisc.edu/esp/drugmetabolismconference

Telephone:

 (608) 262-2422

Fax:

 (608) 262-2431

Dates:

 9/20/2010 to 9/21/2010

Title:

 AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing

Description:

 Goals and Objectives With the establishment of the new Manufacturing Science and Engineering section at AAPS, an annual two to three day themed conference devoted to various aspects of pharmaceutical /biotechnology manufacturing, packaging, engineering and quality is envisioned to be held every year. The conference in 2010 is the first in the series and will be focused on reviewing advances and opportunities in drug product manufacturing with a special focus on continuous manufacturing. While drug product manufacturing has been discussed in various workshops/conferences they have not focused on examples and practical applications of continuous manufacturing, advances in process control, and various approaches for managing risks to product quality throughout the product life cycle. On Day One, the meeting envisions providing a holistic perspective on continuous manufacturing in the pharmaceutical industry, which includes talks from academic, industry and regulatory bodies. The objective of Day Two is to provide an insight into some current approaches for quality risk management during manufacturing which includes adaptation of new techniques for process monitoring and product release as well as implementation of Continuous Verification throughout the product life cycle. Due to the vast field of manufacturing activity, this first conference will address only small molecule drug product manufacturing. A similar conference on biotech manufacturing will be the subject of a future MSE conference. We hope that the attendees will also be able to: gain knowledge about the continuous manufacturing process, determine the advantages of continuous manufacturing and application of QbD and PAT concepts, get a perspective on 'Real Time Release Testing' from companies who are well into such techniques and learn from regulatory bodies their experience of reviewing such applications, gain insight into implementation of quality risk management strategies throughout the product life cycle, e.g. Continuous Verification.

Location:

 Sheraton Inner Harbor Hotel, Baltimore, MD

E-mail:

 meetings@aaps.org

Link:

 www.aapspharmaceutica.com/DPM

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 9/24/2010 to 9/25/2010

Title:

 Third Annual Nanotechnology Symposium

Description:

 Co-sponsored with AAPS Nanotechnology is a rapidly growing industry, incorporating all fields of science and similar studies. The theme "Nano is Too Big" is intended to entice curious persons to dive deeper into the field of nanotechnology, as its future capabilities are seemingly endless. From a pharmacist perspective, Dean Hieu T. Tran, Pharm. D., state "we are looking forward to the advancement of Nanoscience applied to drug delivery and treatment and to forward the translational science initiative, brining nanotech from bench to the patient's bedside." Yashwant Pathak, conference coordinator, strongly believes that the subject is so vast and unlimited, it cannot be overlooked. The sooner nanotechnology is explored and understood, the more humanity can take advantage of its benefits. The education industry, in particular, should be seeking more and more knowledge on nanotechnology. At the First Annual Nanotechnology Symposium, key note speaker Dr. R.P.H. Chang claimed that more than 2 million workers would be required in the field of nanotechnology within the next 10 years. That said, it's time to start preparing the next generation for what to expect with and how to apply nanotechnology. Now is the time to learn about this new and newer technology--NANOTECHNOLOGY! Join us at the 3nd Annual Nanotechnology Symposium to hear about the latest and greatest research and developments in the industry.

Location:

 Sullivan University, Louisville, KY

E-mail:

 pharm@sullivan.edu

Link:

 http://sullivan.edu/pharmacy/NANO-index.asp

Telephone:

 502.413.8640

Fax:

 703-243-5582

Dates:

 9/28/2010 to 10/1/2010

Title:

 Freeze-Drying of Pharmaceuticals and Biologicals

Description:

 The event will include a Short Course, Symposium and exhibition with short presentations by vendors. Presented by: University of Munich, University of Connecticut, and the Dane O. Kildsig Center for Pharmaceutical Processing Research.

Location:

 Garmisch Partenkirchen, Germany

E-mail:

 liz.anderson@uconn.edu

Link:

 http://www.cppr.purdue.edu

Telephone:

Fax:

 +1 860 486 4998

Dates:

 10/4/2010 to 10/7/2010

Title:

 Translational Biology: Pre-Clinical Strategies for Drug Development

Description:

 Turning Pre-clinical data into Clinical Strategy University of Wisconsin-Madison Extension Services in Pharmacy One of the biggest challenges for companies developing pharmaceuticals is the translation from animal models to human subjects. Much of the work required for these translations is required prior to submitting the Investigational New Drug (IND) application. This course will focus on moving promising new chemical entities (NCEs) and new biological entities (NBEs) from animal models to human subjects and the application of PK/PD models’ toxicity data and safety pharmacology towards the development of a strategic human clinical trial program. Handling and early avoidance of serious safety issues will also be addressed in the course. The course should assist scientists in reducing the timeframe required for lead compound development to an IND filing and through early clinical trials. The course will consider both in vitro and in vivo aspects of early drug development and will focus on animal models and the selection of the most relevant models to facilitate translation. Compared to other drug development courses in this series, there will be a more in-depth look at PK/PD modeling, toxicology and customized testing designed to minimize compound safety liability prior to IND filing and preparing for clinical trials. Upon completion of the course the learner should be able to: • Identify the challenges in designing safe and effective drugs; • Explain PK/PD modeling methods used in drug development; • Discuss the importance of safety pharmacology and its role in early lead development; • Describe a variety of relevant animal models and their corresponding advantages and disadvantages; and • Explain the progression and challenges of moving from animal models to human subjects.

Location:

 Madison, WI

E-mail:

 ebuxton@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/courseinfo/2010TranslationalBiology/

Telephone:

 608-265-2259

Fax:

 608-262-2431

Dates:

 10/4/2010 to 10/8/2010

Title:

 Practical Strategies for Developing Preclinical and Phase 1 Oral Drug Formulations

Description:

 This University of Wisconsin School of Pharmacy short course covers practical aspects of dosage form development for preclinical and phase 1 formulations. The formulation approaches include solubilization and disperse phase systems (suspensions, emulsions, microemulsions, liposomes and micelles) for preclinical as well as powders for reconstitution, capsules and tablets for phase 1. The course is a practical guide in that its focus is on major considerations in selecting and evaluating oral dosage forms for preclinical and phase 1 studies by examining the excipients used, their typical level ranges and various preparation/processing procedures on small laboratory and pilot scales. The challenges in developing oral dosage forms at this early stage will be examined in detail, including the major problems encountered and the common strategies that are used to overcome them. In addition to its focus as a formulation guide, the course content includes key points in stability evaluation, such as excipient compatibility approaches and the ICH guidelines. The major physical tests used to assess formulations are an integral part of the course material and are covered in terms of their application to problem solving and in setting the product specification.

Location:

 Madison, WI

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 www.pharmacy.wisc.edu/esp/link/drugdevelopment

Telephone:

 (608) 262-2422

Fax:

 (608) 262-2431

Dates:

 10/4/2010 to 10/6/2010

Title:

 2010 World Stem Cell Summit

Description:

 Co-sponsored with AAPS Your Gateway to the International Stem Cell & Regenerative Medicine Community The World Stem Cell Summit is the flagship international event uniting the stem cell community by bringing together scientists, patients, advocates, business people, investors, educators, ethicists, policy makers, government representatives, and others to network and learn from each other. In 2010, the Summit will attract more than 1,200 attendees from 30 nations, 60 exhibitors and more than 200 endorsing organizations and media partners from around the world.

Location:

 Detroit Marriott Renaissance Center, Detroit, MI

E-mail:

 meetings@aaps.org

Link:

 www.worldstemcellsummit.com

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 10/7/2010 to 10/9/2010

Title:

 Formulation Development and Drug Delivery Systems for Therapeutic Proteins Short Course

Description:

 This course is designed for pharmaceutical chemists, prtein chemists, biochemists, bioanalytical chemists, and those involved in the formulation of protein of peptide drug products or their drug delivery systems. Learn abut bioanalytical methods used in physicochemica characterization of protein peptides and pre-formulation studies, find out how to design and conduct stability programs for protein and peptide drug products, learn chemical modification techniques fuseful in the development of biopharmaceutical drug products, and more.

Location:

 Chicago, Illinois, USA

E-mail:

Link:

 http://www.proed.acs.org

Telephone:

 202-872-4544

Fax:

Dates:

 10/11/2010 to 10/13/2010

Title:

 CMC Project Team Management

Description:

 Principles and Practices for Successful Leadership Sponsored by University of Wisconsin-Madison Extension Services in Pharmacy Successful leadership of NCE/NBE and line extension development teams requires more than generating technical knowledge that is summarized in regulatory filings. This course, accordingly, addresses leadership essentials, team dynamics, meeting mechanics, and decision making styles and mechanisms, all in the context of CMC development. Other important activities typically conducted by the CMC team covered in the course include the preparation, testing, packaging, and labeling of clinical trial supplies and the associated elements of quality assurance and regulatory compliance. In addition, the course covers project planning for regulatory filings, timing of events and interdependencies of the many tasks required to advance a candidate to Phase 1 and beyond. Filing documents are examined, section by section, with a description of the content of each section and the typical level of detail consistent with FDA guidance documents. Attendees will be divided into sub-groups to conduct exercises related to leading the construction and execution of CMC project plans. Each group will create a team structure and a project plan to advance an assigned development program through the various stages of drug substance, drug product and clinical development. Upon completion of the course, the learner should be able to describe: • The role of the CMC team and project manager in the broader context of the entire product development program; • Essentials of project team management, including team dynamics, meeting management, decision making, communication, negotiation and conflict resolution; • Project planning and timing of CMC-related events leading to a regulatory filing; • Key drug substance, drug product, and analytical method development activities as they pertain to regulatory filings; and • The content of Drug Substance and Drug Product sections of an IND and the level of detail consistent with available FDA guidance documents.

Location:

 Madison, WI

E-mail:

 ebuxton@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/courseinfo/2010TechnicalLeadership/

Telephone:

 608-265-2259

Fax:

 608-262-2431

Dates:

 10/11/2010 to 10/13/2010

Title:

 Technical Writing in a Regulated Environment

Description:

 Sponsored by University of Wisconsin-Madison Extension Services in Pharmacy The purpose of technical writing in a regulated environment is to present information in a clear, concise and understandable manner and satisfy the specific needs of various regulatory bodies. Many times the more words we use to make our writing look eloquent, the more we detract from the meaning we intend. When a reader has to spend time studying your sentences to derive their meaning, precious time is wasted. Regardless of field of study or profession it is highly likely that you will have to do lots of communication via writing. The better your understanding of the basic principles of technical writing, the more effective you will be in your academic or professional career. The term “technical writing” is a formal style of writing that is essential in a wide variety of technical fields. Effective technical writing will present clear and useful information to an intended audience. In the pharmaceutical and biotechnology industries alone, we must routinely communicate to scientists, physicians, lawyers, manufacturing staff, marketing staff, accounting staff, senior management, and even regulators. Each of these will have very specific needs regarding information and will require you to alter your writing style to meet those needs. Upon completion of the course the learner should be able to: 1) Discuss the proper use of sentence structure, punctuation, and writing style for technical writing. 2) Describe the various audiences you will be writing to in a regulated environment. 3) Explain the framework for Standard Operating Procedures, Validation protocols and other various GMP documentation. 4) List the best practices for documentation

Location:

 Madison, WI

E-mail:

 ebuxton@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/courseinfo/2010TechnicalWriting/

Telephone:

 608-265-2259

Fax:

 608-262-2431

Dates:

 10/12/2010 to 10/15/2010

Title:

 Third International Symposium on Folate Receptors and Transporters

Description:

 Reduced forms of folic acid (vitamin B9) are essential to numerous bodily functions ranging from nucleotide biosynthesis to repair of DNA, ethylation of DNA, conversion of homocysteine to methionine, and biosynthesis of S-adenosylmethionine. Not surprisingly, rapidly dividing cells, including cancer cells, have an elevated appetite for physiological folates, and therefore, may over-express proteins responsible for uptake of the vitamins. This conference will focus on the pathways of folate transport into cells and the use of these pathways to deliver drugs to cells that over-express the folate receptor or folate transporters.

Location:

 Zion National Park @ Springdale, UT, USA

E-mail:

 rsblack@purdue.edu

Link:

 http://www.chem.purdue.edu/folate/

Telephone:

 765-494-5283

Fax:

 765-494-5272

Dates:

 10/18/2010 to 10/19/2010

Title:

 NanoMedicine Summit

Description:

 The 2010 Cleveland NanoMedicine Summit focuses on an in-depth, up-to-date review of nanomedicine research with an emphasis on translational research and clinical applications. This Summit, cohosted by the Cleveland Clinic and Case Western Reserve University, will continue its incredibly successful format that brings together scientists, clinicians, business professionals, investors, and others to investigate sustainable solutions of multidisciplinary methodologies to further advance the use of nanomedicine in clinical practice.

Location:

 InterContinental Hotel Cleveland Ohio

E-mail:

 stonej3@ccf.org

Link:

 www.ccfcme.org/Nano 10

Telephone:

 216-448-0790

Fax:

 216-448-0782

Dates:

 10/18/2010 to 10/19/2010

Title:

 SBS Biomolecular Screening Symposium

Description:

 Advanced Applications Across Academia, Government & Industry

Location:

 Durham, NC, USA

E-mail:

 tsexauer@sbsonline.org

Link:

 www.sbsonline.org/biomolecular

Telephone:

 1-703-964-1240

Fax:

Dates:

 10/18/2010 to 10/19/2010

Title:

 SBS Biomolecular Screening Symposium

Description:

 Advanced Applications Across Academia, Government & Industry

Location:

 Sheraton Imperial Hotel and Convention Center, Durham, NC, USA

E-mail:

 ajeffrey@sbsonline.org

Link:

 www.sbsonline.org/advancedapps

Telephone:

 1-203-743-1336

Fax:

Dates:

 10/20/2010 to 10/20/2010

Title:

 Solubilization and Enhanced Oral Bioavailability Formulations

Description:

 This University of Wisconsin School of Pharmacy short course covers background and practical aspects of solubilization and enhanced oral bioavailability formulation strategies. The formulations considered are those used in preclinical and clinical, particularly phase 1, programs for low solubility drugs. Preformulation background in solubilization is covered for pH adjustment, cosolvents, cyclodextrins, surfactants and oil-based lipids, with an emphasis on the main excipients, their levels and how to minimize the solubility measurement workload to achieve the desired formulation. The importance of precipitation upon aqueous dilution is considered for these formulations. Nonsolubilization approaches covered are milling, particularly nanomilling, and solid dispersions. The major physical tests to assess milled and amorphous solids are examined in the context of preformulation characterization and problem solving.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/20/2010 to 10/20/2010

Title:

 Validation, Verification and Transfer of Analytical Methods

Description:

 This interactive University of Wisconsin School of Pharmacy short course is designed to provide a life-cycle approach to assuring analytical methods are suitable for their intended use. After an introduction to some of the compendial and regulatory guidance documents on the subject, we will discuss how approaches to method validation change across the life of a product and depend on a variety of situations. The course will then address specific requirements for chromatographic methods intended for monitoring impurities and degradates, chromatographic methods where the focus is on measuring the active ingredient and non-chromatographic methods. For each of these cases, an example of a successful validation will be presented, followed by discussion on how to troubleshoot situations where there are challenges to validation. Upon completion of the course the learner should be able to: 1) describe when it is appropriate to apply method validation, method verification or method transfer principles; 2) discuss the appropriate guidance documents related to method validation, verification and transfer; 3) design and execute method validation experiments; and 4) troubleshoot methods which are not performing well.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/20/2010 to 10/20/2010

Title:

 Multifactor Design of Experiments in Pharmaceutical Development, Manufacturing, and Quality Control

Description:

 Multifactor design of experiments (DOE) is an efficient and effective strategy for assessing the impacts of and the interactions between factors which potentially impact a process. That process can be an API synthesis, a biologics fermentation, product formulation, or an analytical method. DOE combines scientific judgment and risk analysis, together with design and analysis tools to assist the practitioner in exploring their multidimensional process. DOE facilitates the determination of the process design space, a cornerstone of Quality by Design, a new paradigm for pharmaceutical development. It also plays an essential role in manufacturing, where process understanding achieved through implementation of DOE can result in improvements in product quality or yield, as well as manufacturing efficiency. This University of Wisconsin School of Pharmacy short course will introduce the attendee to the tools and software useful for planning and analyzing their experiments. Examples will be utilized to illustrate the implementation of DOE, as well as its successful use in various areas of pharmaceutical development, manufacturing, and quality control. Upon completion of this course the participant should be able to: 1) understand the use of DOE in conventional practices and how it can result in less cost and time while covering a broader range of their process space; 2) use DOE to mitigate the risk of experimental bias, and provide a more scientifically valid assessment of their process; 3) implement the stages of experimentation using DOE, including screening, optimization, and confirmation; 4) choose process factors for experimentation, pick the most efficient design to study their factors, and set factor levels which best reveal their impact on the process; and 5) analyze data from their DOE, including determine which factors are impacting their process, and generate a mathematical model to establish optimal process conditions as well as their process design space.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/20/2010 to 10/20/2010

Title:

 Characterization and Impact of Water-Solid Interactions in Pharmaceutical Systems

Description:

 The purpose of this course is to provide the participant with a basic understanding of the principles that govern the interaction of residual water with pharmaceutical solids, and the effects of such water on the physical and chemical properties of solids. Upon completion of this course the participant should be able to: identify the various modes of interaction between environmental water and solid drugs and excipents in various solid-state forms; 2) understand the relationship between the mode of interaction and the thermodynamic and kinetic states of such water in contact with various solids; 3) critically and quantitatively analyze the relationships between residual water content, relative humidity and temperature; and 4) anticipate and understand, at the molecular level, the effects of residual water on the important solid state properties and instabilities of drugs and excipients.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/21/2010 to 10/21/2010

Title:

 QbD for Solid Dosage Forms: Designing Tablet Formulations Based on API Physical Properties

Description:

 The objective of this course is to provide the participant with an understanding of how fundamental physical properties of APIs impact the design and manufacture of tablet dosage forms. Upon completion of the course the learner should be able to: 1) describe the basic physical properties f powders that are of importance for tablet manufacturing, 2) explain how powder physical properties control flow, segregation and compaction performance, 3) select excipients based on the physical properties of the API, 4) understand the interdependence of the tensile strength, compression stress and solid fraction of the final product; and 5) select tablet manufacturing equipment and conditions to maximize productivity and quality. An emphasis will be placed on practical approaches that can be used for rational tablet design and development in accordance with Quality-by-Design principles. The class will include opportunities for problem solving in small groups and as individuals.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/21/2010 to 10/21/2010

Title:

 Developing and Troubleshooting Dissolution Methods

Description:

 This interactive University of Wisconsin School of Pharmacy short course is designed to provide practical tools for those developing dissolution methods at various stages (including biorelevant methods), and to provide an understanding of the development process for managers, formulators and regulatory affairs/CMC personnel Building on the history of dissolution, learner is presented with a systematic approach to develop dissolution methods. The course emphasizes troubleshooting methods when changes in dissolution profiles are observed, and understanding the causes for those changes, including opportunities to discuss real or hypothetical situations. The topics of biorelevant dissolution, setting specifications and integration of Quality by Design principles are introduced in a manner than facilitates practical implementation. Finally, several key regulatory and compendial documents are discussed to assist the learners in connecting regulatory expectations with their methods. Upon completion of this course the learner should be able to: 1) develop a dissolution method for a pharmaceutical dosage form, using the target product profile and drug substance solubility data; 2) evaluate changes in dissolution profiles and determine probable root causes and potential solutions; 3) describe the principles and application of biorelevant dissolution, setting specifications and Quality by Design principles to dissolution methodology; and 4) list the appropriate regulatory or compendial documents which may be pertinent to the situation under evaluation.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/21/2010 to 10/21/2010

Title:

 Statistical Considerations in Analytical Method Validation

Description:

 Analytical methods are used throughout the pharmaceutical industry to facilitate development and to monitor product quality post licensure. Methods aren’t limited, however, to measurement of product characteristics such as dose, potency, or purity, but are also used to measure the quantity of an analyte in solution or in a biological medium such as blood, or in vivo response to treatment with a drug, a protein, or a vaccine. Regardless of their use or the type of sample tested all methods must possess characteristics which assure reliable decisions from their use. During method validation the practitioner should identify those characteristics which may impact those decisions, then design an effective experiment to demonstrate that the method is “fit for use.” Statistical tools are available to design an efficient and effective method validation, while consideration may be given to the risk of failing the validation when the method is acceptable. Standard methods of analysis may be supplemented with statistical techniques such as equivalence testing using confidence intervals to demonstrate conformance of parameters to validation acceptance criteria, and variance component analysis to identify significant sources of variability and to obtain a representative estimate of intermediate precision. This University of Wisconsin School of Pharmacy short course will cover statistical considerations in method validation, which help demonstrate that the method is fit for use, while protecting the laboratory from earmarking a suitable method as invalid. Validation of traditional methods such as HPLC will be highlighted, while special considerations for methods such as dissolution, bioassay, biomarkers, and bioanalytical methods will also be discussed. Upon completion of this program the participant will be able to: 1) identify validation parameters which impact fitness for use of their method, and establish acceptance criteria which minimize the risk of making the wrong decision from a measurement; 2) understand the value of statistical elements of validation design such as replication to reduce the risk of inappropriately failing the validation, and multifactor DOE to incorporate representative long term factors into the validation study; 3) understand statistical elements of a validation analysis, including how equivalence testing using confidence intervals is used to establish conformance to acceptance criteria, and how variance component analysis to is used to identify significant sources of method variability, and 4) describe how validation study results can be used to establish key development and quality decision rules, which help monitor and maintain method performance, facilitate development, and assure quality product to the consumer.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 10/21/2010 to 10/21/2010

Title:

 Practical Applications of Instrumentation in QbD/PAT

Description:

 Current analytical methods are designed to test APIs with an eye to bioavailability and safety; physical characteristics (particle size distribution, polymorphic shape, particle shapes, solubility and dissolution rate) and chemical parameters (heavy metals, impurities, stability profile with GRAS materials). They assure purity and consistency of only the drug and are specific for each chemical entity. The excipients, under cGMP, are tested only for compendial tests (e.g., bulk density, percent moisture, heavy metals, residue on ignition, sieve size), not for their ability to produce a good product. With pharmaceutical manufacturers not the largest client for excipient suppliers, there is not much chance that excipients will be modified for the product. QbD is based on the concept that the process should be modified to best use available materials. This calls for process monitoring tools, not current before and after production analysis techniques. This University of Wisconsin School of Pharmacy short course describes the numerous tools used to develop PAT and QbD programs. It will clearly show the differences between current methodology and what is needed to perform a successful PAT and/or QbD program. The course will cover available technologies, how they work, what they do, and what may be done with the data generated. It will introduce the concepts of continuous monitoring of Critical to Quality parameters and how they may be applied. Upon completion of the course the learner should be able to: 1) work with instrument suppliers to choose/design the correct technology, 2) describe how to incorporate these technologies into a process stream, and 3) discuss how to use the generated data to determine CtQ (Critical to Quality) attributes then monitor and control them.

Location:

 Somerset, NJ, USA

E-mail:

 jedemuth@pharmacy.wisc.edu

Link:

 http://ce.pharmacy.wisc.edu/course/category.php?id=18

Telephone:

 608-262-2422

Fax:

 608-262-2431

Dates:

 11/13/2010 to 11/14/2010

Title:

 USP Workshop on the Pharmacopeia’s Role in Improving Global Health

Description:

 Co-sponsored with AAPS Goals & Objectives The goal of this workshop is to provide a forum to present perspectives and encourage dialog on topics of global importance to the pharmaceutical industry, regulators, and pharmacopeias, including those of the recent past, those under active debate, and challenges for the future. The topics to be presented include; USP’s elemental impurities (metals) initiative, economically motivated adulteration (problems and solutions), genotoxicity, anti-counterfeiting approaches, challenging new excipients, and critical topics for the biologicals/biosimilars arena. This highly-interactive workshop is divided into five sessions with several objectives. The first session outlines USP’s elemental impurities initiative and will include an overview and discussions of toxicology, instrumentation and regulatory issues. The second session focuses on recent activities to address the ongoing problem of economically motivated adulteration and the pharmacopeia’s changing role in this area. The session will present discussions of lessons learned and future directions for pharmacopeial standards in heparin, glycerin, dietary supplements both in the US and in global commerce. The third and fourth sessions will focus on balanced discussions about topics currently under consideration by the world's pharmacopeias, including genotoxic impurities, anti-counterfeiting technologies, and advances in excipients that challenge the current approval and usage paradigms. The final session will focus on some of the most fundamental issues surrounding the development of standards for biological molecules, their identification and impurities. Presentations on the major topics and a panel discussion to develop recommendations for the global pharmacopeias are planned.

Location:

 Ernest N. Morial Convention Center, New Orleans, Louisiana

E-mail:

 meetings@aaps.org

Link:

 http://www.usp.org/

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 11/13/2010 to 11/14/2010

Title:

 AAPS Workshop on Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource and Complex Drug Products

Description:

 Goals and Objectives This workshop will bring together pharmaceutical scientists from industry, academia and regulatory agencies in different regions and countries to review scientific and regulatory issues in demonstrating therapeutic equivalence and interchangeability of multisource (generic) drug products, including complex drugs. Key messages from this meeting may be published for the scientific community towards a better understanding of differing regulatory approaches and important factors underlying product performance, facilitating a process of global harmonization of therapeutic equivalence requirements in the future. The goals and objectives of this workshop are multi-fold. Review scientific and regulatory approaches for demonstration of pharmaceutical equivalence and bioequivalence of multisource drug products from different regions and/or countries globally. Discuss existing and emerging issues in determining equivalence of drug products, including complex drug products and dosage forms (such as low molecular weight heparins, Fe-sugar complexes, complex peptide mixtures, liposomes and nanotech-derived products). Discuss the white paper on Complex Drug Products. Discuss current bioequivalence criteria using pharmacokinetic measures and pharmacodynamic/clinical endpoints for various types of dosage forms, including highly variable drug products. Examine the role of in vivo and/or in vitro bioequivalence studies in the approval of multisource products and the possibilities of reducing duplication of these studies for different regions, including the choice of a reference listed drug. Consider current regulatory policies on waivers of in vivo bioequivalence studies, discuss available in vitro methods or tools as surrogate for bioequivalence and identify approaches to expanding waivers of in vivo bioequivalence studies. This workshop will provide the forum for an open discussion on scientific and regulatory issues in the area of equivalence, facilitating a process for harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.

Location:

 Ernest N. Morial Convention Center, New Orleans, Louisiana

E-mail:

 meetings@aaps.org

Link:

 www.aapspharmaceutica.com/multisourcedrugproducts

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 11/13/2010 to 11/14/2010

Title:

 ACCP Workshop - 2010 Frontiers Symposium
6th International Symposium on Microdialysis in Drug Research and Development

Description:

 Co-sponsored with AAPS Goals & Objectives To provide a state-of-the-art overview of the current applications of microdialysis in drug research and development. At the completion of the symposium participants should be able to: • Outline the basic concepts of microdialysis, • Apply the method to assess local exposure of the compound of interest in almost any target site, • Appreciate the potential of microdialysis as a pharmacokinetic and pharmacodynamic tool in drug development and clinical monitoring, • Monitor biomarkers and drug penetration in disease conditions, and • Relate the regulatory applications of microdialysis.

Location:

 Ernest N. Morial Convention Center, New Orleans, Louisiana

E-mail:

 meetings@aaps.org

Link:

 https://www.accp1.org/hot_topics/article/2010-accp-frontiers-symposium

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 11/13/2010 to 11/14/2010

Title:

 AAPS Workshop on Contemporary Challenges and Advances Impacting the Development of Veterinary Pharmaceuticals

Description:

 Goals and Objectives This two-day workshop serves the animal health community with rare programming specifically tailored to this field. This workshop will bring together an international, cross-disciplinary audience to examine contemporary challenges and new advances impacting the global animal health industry. Specific objectives are to • review and discuss current Veterinary ICH regulations/regulatory guidances and industry practices related to the globalization of the animal health pharmaceuticals industry, • review and discuss current & emerging tools / models used to characterize and predict the clinical performance of animal health drugs, • review and discuss opportunities and barriers to the expansion of therapeutic options in animal medicine including the introduction of novel dosage forms and use of opiates. Background Meeting the global demand for animal health products requires increased efficiency, smart use of resources and predictive tools, and an expansion of our therapeutic options. Economic considerations have forced the animal health industry to increase dependence on contract research and manufacturing organizations, as well as “in-house” resources located offshore. In order to make the best use of resources and bring innovative products to market as quickly as possible, it is essential to understand worldwide regulatory requirements and guidances. This workshop will highlight regulations and contemporary industry practices that will help the audience better identify opportunities and navigate pitfalls for successful global product registrations. For example, presentations will address the progress of global harmonization under the Veterinary ICH guidelines, leveraging clinical data for worldwide market applications, and impediments to achieving one set of global product specifications. Tools for predicting drug performance are of critical importance to animal health, and also in human health because of the role animal studies play in the early screening and development of human drug candidates. Meeting the demand for fast, efficient ways of screening & evaluating drug candidates requires tools such as validated biomarkers, PK-PD modeling, and an understanding of metabolic differences across species. These and other important tools will be discussed at this workshop. The final workshop topic, Expanding Our Therapeutic Options, includes presentations on improved utilization of existing available drugs such as opiates, advances in biotherapeutics for animal health, as well as the opportunities and impediments to bringing truly novel drugs and delivery technologies to market.

Location:

 Ernest N. Morial Convention Center, New Orleans, Louisiana

E-mail:

 meetings@aaps.org

Link:

 www.aapspharmaceutica.com/VetPharm

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 11/13/2010 to 11/13/2010

Title:

 CRS Workshop on Using Population Pharmacokinetics to Support the Development of Clinically Relevant Specifications for Extended Release Formulations

Description:

 Co-sponsored with AAPS The Quality by Design (QbD) paradigm is ushering in new approaches for achieving a streamlined, knowledge-based process for generating products optimized to meet patient needs. Development of a Quality Target Product Profile (QTPP) can help maximize the likelihood of achieving the therapeutic objective by linking critical product quality attributes (CQAs) to the desired in vivo performance. In this workshop, we will discuss developing a QTPP through PK/PD modeling and simulation approaches that will enable linking CQAs to clinical outcome. Through the integration of population PK/PD models established on the basis of clinical trial data, this integrative approach could ensure the establishment of in vitro drug dissolution/release methods that link to the desired in vivo product performance, thereby providing dissolution/release criteria that are consistently informative and clinically relevant. WHO SHOULD ATTEND: bench and clinical scientists involved in the development or regulation of modified release formulations and the optimization of dosing strategies.

Location:

 Ernest N. Morial Convention Center, New Orleans, Louisiana

E-mail:

 meetings@aaps.org

Link:

 www.controlledreleasesociety.org/

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 11/14/2010 to 11/18/2010

Title:

 FIP Pharmaceutical Sciences World Congress 2010 in Association with the AAPS Annual Meeting and Exposition

Description:

 Every three to four years, the International Pharmaceutical Federation (FIP) organizes a Pharmaceutical Sciences World Congress (PSWC). The PSWC series alternates among the American, Asian, and European continents; the Americas will host the 2010 PSWC. Each year, the American Association of Pharmaceutical Scientists (AAPS) organizes the AAPS Annual Meeting and Exposition. In 2010 FIP and AAPS have agreed to hold the PSWC and the AAPS Annual Meeting together in New Orleans, Louisiana, USA from 14–18 November. FIP and AAPS also agree that the objective of this joint meeting should be for the education and benefit of the members of each organization and the constituencies that they represent. The programming, exposition, and other events will provide maximum educational opportunities. The joint meeting will include: A forum for the exchange of ideas and information about the sciences that the organizations represent Continuing professional development for individual members and related professionals An introduction of the latest technological advances The scientific theme is: Improving Global Health Through Advances in Pharmaceutical Sciences. The Scientific Programming Committee is geographically balanced with members from the Americas, Asia, and Europe.

Location:

 Ernest N. Morial Convention Center, New Orleans, Louisiana

E-mail:

 meetings@aaps.org

Link:

 www.pswc2010.org

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 11/15/2010 to 11/18/2010

Title:

 2010 Pharmaceutical Freeze Drying Workshop

Description:

 This PDA workshop will start with an overview on science and technology of freeze drying and will give an update on the latest technical developments. In the afternoon there will be three concurrent workshops on development, production and special challenges/freeze drying of potent and temperature-sensitive products. The concurrent workshops will have case study presentations and plenty of time to discuss current issues with industry experts, colleagues and presenters. Held in conjunction with the 2010 Pharmaceutical Freeze Drying Workshop is the PDA Training and Research Institute course, Fundamentals of Lyophilization, November 15-16, 2010. The course instructor is Edward H. Trappler, President, Lyophilization Technology, Inc.

Location:

 Sheraton San Diego Hotel Marina, San Diego, CA

E-mail:

Link:

 http://www.pda.org/freezedry2010

Telephone:

Fax:

Dates:

 11/22/2010 to 11/24/2010

Title:

 Tabletting technology for the pharmaceutical industry

Description:

 This up-to-date and well-established three-day residential course, organised in partnership with the Academy of Pharmaceutical Sciences, provides the solution. The course is an intensive introduction to tabletting and the associated processes and delegates will leave the course with knowledge they will be able to apply to day-to-day problems in tabletting. The course offers delegates the unique opportunity to discuss real challenges faced in day-to-day work with the expert lecturers and delegates are encouraged to send in advance, or bring to the course, their own problems in tablet formulation or production for discussion.

Location:

 Moller Centre, Cambridge

E-mail:

 events@rpsgb.org

Link:

 http://www.rpharms.com/development/tabletting-course.asp

Telephone:

 02075722640

Fax:

Dates:

 11/29/2010 to 12/2/2010

Title:

 From Construct to Clinic

Description:

 Advanced Course on the Development of Biotech Drugs

Location:

 The Netherlands, Leiden

E-mail:

 w.jiskoot@lacdr.leidenuniv.nl

Link:

 http://www,brpl.nl

Telephone:

 *31 71 527 4314

Fax:

 *31 71 527 4565

Dates:

 12/7/2010 to 12/9/2010

Title:

 Innovation in Drug Discovery: Science & Technology

Description:

 Society for Biomolecular Sciences' First Annual China Conference

Location:

 Shanghai, China

E-mail:

 tsexauer@sbsonline.org

Link:

 http://www.sbsonline.org/china

Telephone:

 1-703-964-1240

Fax:

Dates:

 3/6/2011 to 3/11/2011

Title:

 46th Annual Arden Conference: Pharmaceutical Development of Biologics:

Description:

 BACKGROUND Biopharmaceuticals continue to represent the fastest growing segment of the global pharmaceutical industry. High throughput cell line selection and protein variants production have notably shortened the discovery and lead identification cycle for biologic drug development. Biologics are generally not amenable to oral route delivery due to their intrinsic molecular properties. Injectable dosage forms have therefore become the common choice for initial commercial development. However, injections are invasive and patient perception is generally less than pleasant, resulting in dosing compliance and market acceptability issues. In addition, competitions from biosimilars (biogenerics) have increasingly become a reality. Consequently, development of various sustained release formulations and non-invasive delivery technologies have been a main focus of product enhancement and life-cycle management for many innovator biopharmaceuticals. The primary goal is generally to reduce injection frequencies as well as possibly improve safety and efficacy profiles at the same time. As regulatory guidelines for biologics are not as well established as for small molecule drugs, regulatory paths for development and approval of biologics are often more challenging. GOALS AND OBJECTIVES This program is designed to provide a comprehensive review of biologic drug development, commonly encountered issues, challenges, and recent advances in bioprocess, formulation, delivery, and manufacturing technologies. Detailed presentations will cover four development areas: biological drug substance and preformulation; formulation, delivery and process development; analytical technologies and PAT; and regulatory landscape and biosimilars. Each topic will include lectures from experts in the field followed by interactive group discussions and case studies in which the audience is strongly encouraged to participate. Attendees are also encouraged to bring practical examples of issues and problems encountered at work for discussion and thought exchange, including success stories as well as lessons learned.

Location:

 The Thayer Hotel, West Point, NY, USA

E-mail:

 meetings @aaps.org

Link:

 www.aapspharmaceutica.com/ardenconference

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 3/14/2011 to 3/16/2011

Title:

 AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside

Description:

 Background:
The area of drug transport continues to evolve rapidly, ex. advances in understanding the role of transport in drug absorption, distribution, and excretion, as well as toxicity and disease; improvements in clinical translation of in vitro and preclinical transport studies; and increased regulatory expectations for understanding transport interactions (2010 EmEA draft DDI guidance and 2010 ITC whitepaper). For the past decade, the AAPS Workshop on Drug Transport has been the only recurring North American meeting dedicated to discussion of advances in this field, and has a consistent record of relevance to pharmaceutical scientists. The 2011 Workshop will continue to provide a venue for focused interactions with drug transport experts and thought leaders.

Objectives:
The recognition of the influence of membrane transporters on drug disposition has driven a surge in drug transport-related research activities within the pharmaceutical sciences. Although considerable progress has been made over the past 15 years, the field of drug transport continues to evolve, particularly with respect to clinical translation of in vitro/preclinical data (2010 EmEA draft DDI guidance and 2010 ITC whitepaper), understanding systemic/tissue exposure implications, toxicity/disease pathogenesis, targeting transport for drug delivery, and interplay with metabolism. The AAPS Workshop on Drug Transport aims to continue on the success of this meeting previously held in 2003, 2005, 2007, and 2009, and to provide an opportunity for pharmaceutical scientists to exchange ideas about the cutting-edge science in this field. Key areas of focus will include:

• Update on most recent developments in the field,
• In vitro-to-in vivo and preclinical-to-clinical translation of transport data,
• Implications of the ITC whitepaper and revised EmEA draft DDI guidance to drug development,
• Transport strategies for drug discovery,
• The role of drug transporters in toxicity/disease,
• Transporters as determinants of drug exposure and targeting transporters as drug carriers,
• Interplay between metabolism and transport,
• Incorporation of transport into in silico, PBPK, and PK/PD models,
• Current understanding of clinical implications of transporter polymorphisms.

Location:

 Bethesda North Marriott Hotel & Conference Center, Bethesda, MD

E-mail:

 meetings@aaps.org

Link:

 http://www.aaps.org/meetings/workshops/DrugTrans

Telephone:

 703-243-2800

Fax:

 703-243-5582

Dates:

 3/27/2011 to 3/31/2011

Title:

 SBS 17th Annual Conference & Exhibition

Description:

 Advancing the Science of Drug Discovery

Location:

 Gaylord Palms Resort and Convention Center, Orlando, Florida, USA

E-mail:

 tsexauer@sbsonline.org

Link:

 www.sbsonline.org/orlando

Telephone:

 1-703-964-1240

Fax:

Dates:

 3/31/2011 to 4/1/2011

Title:

 16th Congress of the European Association of Hospital Pharmacists

Description:

 Congress Focus: Hospital Pharmacists in a changing world - opportunities and challenges.

Location:

 Vienna, Austria

E-mail:

 congress@eahp.eu

Link:

 http://www.eahp.eu/

Telephone:

 +32-2-741-24-36

Fax:

 +32-2-734-79-10

Dates:

 5/16/2011 to 5/19/2011

Title:

 2011 AAPS National Biotechnology Conference

Description:

 The 2010 AAPS National Biotechnology Conference will be taking place May 16 –19, 2010 at the Hilton San Francisco Union Square in San Francisco, California. Attendees will have access to one full week of educational programming during this annual event devoted to advancing health through innovations in biotherapeutics. The week begins with the AAPS Workshop – Strategies to Address Therapeutic Protein Drug Interactions during Clinical Development, taking place May 15 –16. Also, the two-day 2010 AAPS Immunogenicity Training Course: Development of Ligand Binding Analytical Methods to Support Immunogenicity Testing Theoretical to Practical Considerations will be taking place May 15 –16. And, the AAPS Short Course, Introduction to the Challenges of a New AAPS Focus Group: Therapeutic Protein Immunogenicity, will be taking place May 16. The week then proceeds through the full 2010 AAPS National Biotechnology Conference programming. The 2010 programming consists of a Plenary Session, Symposia, Roundtables, Posters, and Hot Topics. The week concludes with two short courses. Additionally, an Exposition Hall will be hosting major companies. If you have any questions about the program or registration procedures, please contact the AAPS office at +1 703-243-2800, or, you can send an email to meetings@aaps.org. The 2010 AAPS National Biotechnology Conference is designed to provide a complete educational event allowing each and every attendee the ability to customize their experience with the goal of advancing health through innovations in biotherapeutics. See you in San Francisco!

Location:

 Hilton San Francisco Union Square, San Francisco, CA

E-mail:

 meetings@aaps.org

Link:

 www.aapspharmaceutica.com/NationalBiotech

Telephone:

 703-243-2800

Fax:

 703-243-5582