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Sunday, June 26 • 8:30am - 12:00pm
#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in designing individual clinical trials and overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval.

This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples and case studies that illustrate approaches to adopt or to avoid.

Who should attend?

This tutorial is designed for professionals with basic knowledge in regulatory affairs, agency submissions, and regulatory medical writing.

Learning Objectives

• Identify ways to increase the efficiency and success of product development programs;
• Describe key principles for successful regulatory interactions during drug development and marketing application preparation;
• Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents.


Speakers
avatar for Elaine Taylor

Elaine Taylor

Exec Dir, Reg Consulting, INC Research
Elaine Taylor is Senior Director of Regulatory Consulting and Submissions at INC Research responsible for consultation and the development and management of regulatory interactions and submissions for sponsors. With over 25 years’ experience in pharmaceutical drug development, she has extensive knowledge of ICH and CTD guidelines, 505(b)(1), 505(b)(2), and ANDA drug programs. Her current responsibilities include regulatory strategy, overall... Read More →
avatar for Kathryn Wekselman

Kathryn Wekselman

Senior Director, Regulatory and Scientific Affairs, CTI Clinical Trial and Consulting Services
Kathryn Wekselman is Senior Director of Scientific and Regulatory Affairs at CTI Clinical Trial and Consulting Services in Cincinnati, OH. Before joining CTI in 2012, she worked for 5 years at CROs as a Director and Senior Director of regulatory consulting and submissions for pharmaceutical and biotechnology company clients and for 9 years at Procter & Gamble Pharmaceuticals, where she held positions as a Senior Scientist in medical writing... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA