Workshops

Guidance Forum

Join us for an open dialogue discussion to gain insight into two recent guidances for submission of regulatory applications.

AAPS Annual Guidance Forum

Sheraton Silver Spring
Silver Spring, Md.

September 11-12, 2018

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PharmSci 360

Join the conference early by registering for a variety of Workshops and Short Courses we offer. 


AAPS PharmSci 360

Walter E. Washington Convention Center
Washington, DC
November,  2018


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PharmSci 360 Workshops and Short Courses 


Saturday, November 3, 2018 (Pre-Conference Activities)
  • 9:00 am–5:00 pm (1 day) — (WS1) Flight Simulator Workshop: Learning How to Develop Complex Generic Drug Products
  • 9:00 am–5:00 pm (1.5 day) — (SC1) Surfactants and Biopharmaceuticals – A Love-Hate Relationship
  • 9:00 am–5:00 pm (1.5 day) — (SC2) Development of Fixed Dose Combination Products; Considerations of GI Physiology and Overall Development Strategy
  • 1:00 pm–5:00 pm (0.5 day) — (SC3) Immunogenicity Risk Assessment Update for Biologic Proteins and Peptides
  • 1:00 pm–5:00 pm (0.5 day) — (SC4) A Harmonized Strategy for the Regulatory Submission of Immunogenicity Validation Data
Sunday, November 4, 2018 (Pre-Conference Activities)
  • 9:00 am–5:00 pm (1 day) — (SC5) Science and Risk Based Stability Strategies: Applications of Predictive Tools
  • 9:00 am–1:00 pm (1.5 day) — (SC1) Surfactants and Biopharmaceuticals – A Love-Hate Relationship
  • 9:00 am–1:00 pm (0.5 day) — (WS2) Bioanalytical Method Validation: The Finalized Guidance
  • 9:00 am–1:00 pm (1.5 day) — (SC2) Development of Fixed Dose Combination Products; Considerations of GI Physiology and Overall Development Strategy
  • 9:00 am–1:00 pm (0.5 day) — (SC6) Quantitative-System-Pharmacology: Why, How and When in Drug Discovery and Development
  • 9:00 am–1:00 pm (0.5 day) — (SC7) Immunogenicity Data Evaluations and Clinical Interpretation

Short Course: Surfactants and Biopharmaceuticals – A Love-Hate Relationship

This is a course designed to cover the topic of "Surfactants in Biopharmaceuticals" in a comprehensive manner for the practicing pharmaceutical scientist. It will provide a cross-disciplinary view of this topic starting from synthesis to use, analytics, control, safety, and regulatory aspects.


Workshop: Flight Simulator: Learning How to Develop Complex Generic Drug Products

This practical, active-participation workshop will help participants learn how to approach a demonstration of API sameness and BE for each type of CGDP and how to engage with the FDA about different types of questions during the development of a CGDP. Workshop participants will learn how to efficiently de-risk CGDP development, increase certainty about regulatory decision making, and enhance patient access to high-quality CGDPs.

Short Course: Development of Fixed Dose Combination Products; Considerations of GI Physiology and Overall Development Strategy

This short course will offer a comprehensive view of the most influential aspects of the GI physiology on the absorption of drugs and current techniques to help understand the fate of orally ingested complex drug products in the complex environment represented by the GI tract.

Short Course: A Harmonized Strategy for the Regulatory Submission of Immunogenicity Validation Data

The event will provide a detailed update of current expectations for immunogenicity validations and a preview of the ADAH recommendations. Presentations and discussions will prepare workshop attendees for future regulatory submissions.

Workshop: Science and Risk Based Stability Strategies: Applications of Predictive Tools

This workshop is designed to clarify the applicability of science and risk based stability approaches to optimize the stability protocol in order to develop an in depth knowledge of stability performance of pharmaceutical products (APIs and drug products).

Short Course: Immunogenicity Risk Assessment Update for Biologic Proteins and Peptides

This event will provide a timely update, describing updates to a range of methodologies to predict and measure Td immune responses to protein drugs. Benefits and limitations of current in-silico and in-vitro assay methods, in-vivo animal models including different humanized mouse formats in the field of Immunogenicity Risk Assessment will be discussed.

Workshop: Bioanalytical Method Validation: The Finalized Guidance

On May 18, 2018 the FDA issued the final version for the Guidance for Industry Bioanalytical Method Validation. The purpose of the workshop is highlight the new elements of the Guidance and provide a space for regulators to respond to audience questions using an open forum and panel discussion format.

Short Course: Immunogenicity Data Evaluations and Clinical Interpretation

This short course will provide an overview of regulatory expectations and experience with data reviews, in-depth statistical guidance for a broad range of topics, case-study illustrations of some common challenges, along with a demo of some simple data analysis templates/tools.

Short Course: Quantitative-System-Pharmacology: Why, How and When in Drug Discovery and Development

This short course will offer a holistic approach to understand the vital role of QSP by taking a step-wise approach to its application throughout the drug development process. Through the use of real world case studies and examples, this course provides a unique opportunity for attendees to better understand the rapidly growing field of QSP as well as appreciate how it can be applied immediately to their work.

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