Essentials for Regulatory Affairs for Pharmaceutical Scientists eLearning Series
"The AAPS eCourse Essentials of Regulatory Affairs for Pharmaceutical Scientists eCourse was created as an introduction to regulatory science and the intricacies of the field including regulatory process for market approval, compliance, and regulatory intelligence. In order to meet the latest demands of expanding into emerging markets, the course also has two lectures covering market approval around the globe."
—Shelley Durazo, Ph.D. Candidate
Overview | Preview | Pricing | CE Credit
The objective of this course is to provide an overview as well as cross-functional training in regulatory sciences to better understand current regulatory processes from discovery to commercialization of pharmaceutical products. Designed with pharmaceutical scientists in mind, this series offers information on:
- The purpose and governance of domestic and international regulatory agencies
- U.S. regulatory processes from early through late stage development
- Domestic and international regulations that govern development, manufacturing, and distribution of pharmaceutical and biopharmaceutical products
- Key tools, including regulatory intelligence, to navigate through the complex regulatory environment and stay current on regulations
This training course was developed for pharmaceutical scientists that are:
- Students entering the work force
- Formulation, preclinical, and clinical scientists
- Early stage regulatory science professionals
- Non-scientists such as venture capitalists and angel investors
See a full listing of AAPS Regulatory Affairs 101's lecture titles, instructors, reviewers, and CORE team members and view our informational brochure!
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Previews of each of the lectures are available! All previews can be viewed on the AAPS Regulatory Affairs 101 website.
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View previews and purchase AAPS Regulatory Affairs 101. »
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Single Lecture Pricing
||Per Lecture Price
Full Course Pricing
Purchase the entire course at an even greater discount! This includes all ten modules.
||Full Course Price
Bulk pricing is available. For bulk pricing information, contact Meredith Weston at WestonM@aaps.org.
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Continuing Education Credit for Pharmacists
Pharmacists can receive 15 hours of continuing education credit for completing this ecourse!
||Full Course Price with CE Credit
||$799.00 + $80.00 = $879.00
||$639.00 + 80.00 = $719.00
||$359.00 + $80.00 = $439.00
This brand new comprehensive AAPS online training course was developed for those interested in learning more about the field of regulatory affairs from the perspective of a pharmaceutical scientist. This course will discuss the expansion of marketing pharmaceutical products in emerging markets such as Brazil, Russia, India, and China and how global regulations impact the current drug development process. Upon completion of this eCourse, the participant should be able to:
- Describe the evolution of drug regulation in the United States;
- Explain the various guidances, documents and meetings that are part of the drug development pathway;
- Describe the regulatory expectations and various components for an investigational new drug application (IND);
- Describe how to build the quality module of a new drug application (NDA);
- Discuss the post-approval requirements and where specific details of these requirements can be found (e.g. approval letter, cGMPs, FDA guidances & website);
- Describe various Canadian and European regulations regarding drug applications and pharmacovigilance;
- Discuss quality by design and statistical procedures as they relate to quality target product profiles, critical quality attributes and risk assessments;
- Describe the meaning, importance and key components of Regulatory Intelligence (RI);
- List some of the global regulatory challenges and their impact on future drug development; and
- Describe pharmaceutical company compliance with the various regulatory requirements associated with different countries, regulatory agencies and Pharmacopeias.
The Division of Pharmacy Professional Development at the University of Wisconsin-Madison School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been approved for a maximum of 15 hours (1.50 CEUs) of pharmacy continuing education credit. Credit is based on documented program attendance and completion of an electronic version of the Program Evaluation/Post-Assessment with automatic electronic submitted of credit information to the National Association of Boards of Pharmacy.
Universal provider number: 0073-9999-14-571-H03-P
Expiration date: June 30, 2016
Release Date: June 1, 2014
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