OBJECTIVES

The objective of this module is to provide you knowledge and understanding of the concepts and principles in pharmacovigilance globally with a focus in North America such as :

1. An overview of the concepts and principles of vaccines pharmacovigilance in USA

2. A review of the current pharmacovigilance requirements for Gene Therapy including clinical development and long-term follow-up, pharmacovigilance complexities with regard to different type of Gene Therapy as described within FDA guidance, EU perspective for development of ATMP and high level understanding of ethical consideration

3. An overview and classification of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) followed by HCT/Ps development and regulatory requirements 

4. Understand the current therapeutic landscape of cancer therapy, learn about the history of targeted therapeutics, and their classification, understand how targeted therapeutics differ in their adverse event profile and reporting, appreciate specific regulatory differences in the US FDA regarding targeted therapeutics, understand the future directions of targeted therapies and understand the current therapeutic landscape of cancer therapy

vaccines, gene therapy, clinical development, FDA guidance, ethic consideration, HCT/Ps, targeted therapies, cancer therapy, ATMP

MODULE PARTS

1. Vaccine Pharmacovigilance
2. Gene Therapy
3. Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT Products)
4. Targeted therapy

TRAINER TEAM

Coordinator: Dr Veronique Kugener (from Takeda)

Expert(s): Dr Sherael Webley (from University of Hertfordshire), Prof Miriam Sturkenboom (from University Medical Center Utrecht), Prof Bruno Stricker (from Erasmus Universitair Medisch Centrum), Dr Jens-Ulrich Stegmann, Dr Peggy Webster (from GlaxoSmithKline Research and Development Ltd), Department Of Medical Pharmacology (from Université de Bordeaux), Dr Marina Malikova (from Boston University School of Medicine), Dr Maribel Salas (from Daiichi-Sankyo), Dr Abimbola Cole (from Takeda), Nasop Experts Group (from ISoP's North American chapter), Dr Sepideh Habibi (from CRISPR Therapeutics), Dr Pinak Joshi (from Technical Resources International).