Regulatory Requirements Across the Product Development Lifecycle


Part 1: Wednesday, January 27, 2021 | 1:00 PM 4:00 PM (US ET)

Part 2: Wednesday, February 3, 2021 | 1:00 PM 4:00 PM (US ET)

Part 3: Wednesday, February 10, 2021 | 1:00 PM 4:00 PM (US ET)

Lead Instructor: Chris Vessely

Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, Biologics Consulting Group Inc.

Christina Vessely, PhD, RAC, has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

Series Description

The successful development of a pharmaceutical product requires good science as well as compliance with FDA regulatory expectations. This course includes a comprehensive review of the Chemistry, Manufacturing and Controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.

Who Should Attend

People contributing to CMC sections for regulatory filings. This may include analytical scientists, process development specialists, regulatory affairs specialists, quality control and quality assurance specialists. The course is intended to help you understand where to start, and how to optimize regulatory strategy with an eye on a successful filing.

Part 1: Establishing a Regulatory Strategy that Relates to Your Product Development

Transitioning a program from the laboratory to the clinic, and ultimately through commercialization, is not a simple process. A typical development program takes 1-5 years to transition from early research to first in human studies, and another 5-10 years to progress through the clinical stages toward commercialization. Optimization of your development program will enable you avoid pitfalls and reduce the time to complete each stage.

Part 1 Topics to be Covered:

  • Product development planning
  • Where to find relevant guidance documents
  • Is there a phase dependency to the requirements?
  • Common roadblocks
  • Managing CMOs/CROs

Part 2: Authoring an Acceptable Submissions to the Regulatory Agency: What Are the Filing-Enabling Activities at Different Program Phases?

Great science does not guarantee regulatory success. Getting your product into the clinic or to the commercial market requires communication of the product and its development to the regulatory authorities. The objective of this portion of the course Is to enable you to learn how and when best to communication with the agency.

Part 2 Topics to be Covered:

  1. Interaction with the FDA
    • Meeting types
    • Timing
  2. Introduction to the CTD
    • What are the sections
    • What type of information is included in each section
    • What level of detail is required and is there a phase dependency

Part 3: NDA/BLA and Beyond: Filing Submissions, Inspections Preparation And Post-Approval Requirements

A successful product development program does not end at the time of BLA or NDA filing. Instead, those activities kick off another phase of the program in which must run, to some extent, in parallel with the later stages of the submission preparation process, and beyond. The goal is to be able to demonstrate compliance with GMP and regulatory expectations, not just at the time of filing but through the product lifecycle. This provides an assurance to the agency that product quality and safety will be maintained post marketing.

Part 3 Topics to be Covered:

  • NDA/BLA filing enabling activities
  • Types and reasons for agency inspections of manufacturing and testing facilities
  • Preparation for a pre-approval inspection
  • The inspection itself
  • Post approval commitments