Regulation of Biologics
This learning journey is designed to introduce the regulation of biologics, applicable guidelines, considerations, challenges, and information on the approval process. Both the US and EU regulatory schemes are discussed in this journey.
Table of Contents
- Legal evolution of drug approval and definition of terms
- ICH guidelines including safety
- Regulatory considerations for cellular and gene therapy products – opportunities for interaction with FDA
- Advanced therapy medicinal products – route of approval in Europe
- Regulation of medical device combination product
- Regulatory challenges of accelerated vaccine development
- Drug approval tracks and New Drug Application
- New Drug Approval package and activities after submission
- FDA review and approval
1. Legal evolution of drug approval and definition of terms
By Prof. Martin Edelman – Fox Chase Cancer Center, USA
An excerpt from Development of a cancer drug
2. ICH guidelines including safety
By Dr. Claudette L. Fuller – Merck Research Laboratories, USA
An excerpt from Overview of nonclinical safety assessment
3. Regulatory considerations for cellular and gene therapy products – opportunities for interaction with FDA
By Dr. Larissa Lapteva – Center for Biologics Evaluation and Research, FDA, USA
An excerpt from Development and regulation of cellular and gene therapy products: FDA perspective
4. Advanced therapy medicinal products – route of approval in Europe
By Dr. Ana Hidalgo-Simon – European Medicines Agency, The Netherlands
An excerpt from Regulation of ATMPs in Europe: present and future
5. Regulation of medical device combination product
By Dr. Christine L. Lanning – Merck & Co., Inc., USA
An excerpt from Biological safety testing: supporting medical device combination products
6. Regulatory challenges of accelerated vaccine development
By Dr. Jakub Simon – Director of Clinical Research, Vaccines, Merck Research Laboratories, USA
An excerpt from Challenges of accelerated vaccine development
7. Drug approval tracks and New Drug Application
By Prof. Martin Edelman – Fox Chase Cancer Center, USA
An excerpt from Development of a cancer drug
8. New Drug Approval package and activities after submission
By Prof. Michael Kinch – Stony Brook University, USA
An excerpt from Drug development: from discovery to manufacture
9. FDA review and approval
By Prof. Martin Edelman – Fox Chase Cancer Center, USA
An excerpt from Development of a cancer drug