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By Monica Lee Whitmire

Monica Whitmire-finalStaying informed of regulatory affairs and staying abreast of the global regulatory landscape is critical to efficient and effective drug development and productive regulatory interactions, quality efficient submissions, and post-launch activities. Informed pharmaceutical scientists help present patients with various medicine options sooner rather than later. Pharmaceutical scientists who are able to proactively incorporate contemporaneous internationally relevant regulatory compliant study designs and appropriate statistical evaluation of data can greatly facilitate the project progression from early development, through GLP toxicology, safety and efficacy evaluations, first in human clinical studies, phase I, II, and III human clinical studies and successful market introduction. Filing post approval changes and adverse event reporting are also critical attributes of all products. Navigating the domestic and international regulatory landscape can be a daunting task. Thorough understanding of the requirements for a comprehensive CMC section of your IND filing can greatly enhance your success.

A very unique opportunity will present itself at this year’s 2014 AAPS Annual Meeting and Exposition in San Diego. A professional development session will be presented by four pharmaceutical science-regulatory experts: Monica Lee Whitmire, Lynn Gold, Kim Huynh-Ba, and Shanthi Sethuraman. This session will be an in-person overview of the ten topics described in detail in the AAPS eLearning course titled AAPS Regulatory Affairs 101: Essentials for Regulatory Affairs for Pharmaceutical Scientists eLearning Series. The primary objective of this ecourse is to provide an overview and cross-functional training of regulatory sciences to better understand current regulatory processes from discovery to commercialization of pharmaceutical products and approaches to be better informed in real time about the changing environment of the regulatory landscape. This will be a unique opportunity for the audience to ask the experts questions and get real time answers regarding contemporaneous regulatory science challenges and opportunities. This unique venue will help our audience of students, novice professionals, and entry level to mid-career regulatory scientists become well equipped in pharmaceutical regulatory processes from a domestic and international perspective. This two-hour professional development session will cover the following topics:

  1. Introduction to Regulatory Sciences.
  2. Regulatory Processes Leading to IND and NDA Submissions: The role of regulations in early phase development and the final new drug application processes.
  3. Commercialization and Post Submission Support session will discuss post-approval requirements.
  4. Regulatory Responsibilities to Ensure Product Quality: Quality Systems, Quality by Design (QbD): Designing the drug to meet the needs of the patient is a critical component of drug development that ensures consistently safe and efficacious medicines to patients throughout the lifecycle of the medicines.
  5. A Close Look at Chemistry Manufacturing and Controls (CMC) Sections: The law (CFR), Regulatory Guidance’s and the integration of data, science, quality and a story for the Agency review.
  6. Global Regulatory Affairs Processes in the Emerging Markets, Europe (EMA), and Canada (Health Canada) describes critical European and Canadian regulations regarding drug applications and pharmacovigilance, and their impact on future drug development.
  7. Regulatory Intelligence, Staying Informed and Regulatory Compliance Requirements: Staying abreast of the global regulatory landscape with respect to compliance, requirements, guidance’s and best practices helps pharmaceutical companies get drugs faster to the patients globally and meets the unmet medical needs of the patients.
  8. Question & Answer.


Please join us for this unique professional development session at the 2014 AAPS Annual Meeting and Exposition on Tuesday, November 4, from 8:00-10:00 am in room 31AB of the San Diego Convention Center. Add this meeting to your schedule on the AAPS Web app today!

Monica Lee Whitmire, M.S., is an ASCP Certified Medical Technologist with 26 years of experience in the pharmaceutical industry: 18 years in big pharma and eight years in CROs. She earned a master’s in microbiology from The University of Wyoming, a bachelor’s in medical technology from The University of Wyoming, and a bachelor’s in microbiology from The University of Wyoming.