In an original clinical trial application (CTA) or investigational new drug application (IND) for a FIH trial, companies are primarily required to provide information on the safety and quality of the drug (or biologic) to support clinical studies. These summaries are expected in regulatory submissions and are particularly useful for supporting the mechanism of action of drugs and biologics.
While estimates vary widely based on indication, therapeutic modality, and novelty, recent analysis suggests that nonclinical testing can cover nearly half of all drug development. In addition, the need for nonclinical data from in-vitro, in-silico, and animal models generally extends well past the point of IND/CTA clearance in the form of supportive data for various waivers, designations, and labeling.
Unfortunately, much of this information is not readily available outside of the clinical setting. This workshop will provide an overview of the pertinent international and regional guidance from ICH, EMA, FDA, OECD and others that shape nonclinical development programs. It will include a discussion of how these components fit together to form the basis for regulatory decision making, and importantly, how this basis can help streamline the transition of a product into the clinic and into the market.
Registration Fees & Deadlines
2 August 2023 – 13 November 2023: Regular $495 Member | $580 Nonmember
14 November 2023 – 14 December 2023: Regular $580 Member | $680 Nonmember
Learning Objectives
Upon the conclusion of the program, you will be able to:
Identify key global and regional guidance directing the content and timeline for completion of various aspects of a nonclinical development program.
Understand how product and indication specific guidance, as well as basic science can influence regulatory expectations and program planning.
Understand how nonclinical data can be leveraged to support key clinical planning decisions.
Who Should Attend?
Individuals seeking to increase their understanding of nonclinical drug development in preparation for taking the RAC-Drugs exam. Medical writers and other professionals involved in assembling key components of the regulatory dossier, including Modules 2.4/2.6; nonclinical summaries found in the Investigator’s Brochure, Clinical Trial Protocol, General Investigation Plan, etc.; and justifications for various waivers (pediatric plans, TQT, carcinogenicity, etc.) Professionals involved in developing a comprehensive and efficient strategy to appropriately derisk the drug development process for a drug product with at least one novel component.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Faculty
David Horton
Director, Global Regulatory Strategy, AbbVie
Tyler Vandivort
Director, Regulatory Affairs and Operations, Amplicore Pharma
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org