Pharmacovigilance for Biologics

Let us guide you through the Pharmacovigilance for Biologics topic and get the necessary knowledge and skills to do it right

  •  Degree
  •  75h workload
  •  Intermediate level

The objective of this module is to provide you knowledge and understanding of the concepts and principles in pharmacovigilance 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. A review to 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

What will you learn

At the end of this module, the successful trainees should

  • Have an understanding and working knowledge of those aspects of pharmacovigilance which are unique to vaccines, and the regulatory requirements and framework for vaccine safety in the United States.
  • Understand the view of the US regulators on Gene Therapy and EMA perspective of the advance therapies. In addition, it will provide you with an understanding on Pharmacovigilance and ethical complexities associated with them.
  • Become familiar with different types of HCT/P products and select safety monitoring strategy based on streamline approach and primary mode of action and acquire knowledge on Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of HCT/Ps
  • Understand the current overall landscape of cancer therapy and adverse events related to targeted therapies

What’s included

  • Videorecorded lectures
  • Lecture slides and supplemental reading materials
  • Discussions with experts
  • Progressive course assessment quizzes
  • Post Graduate degree in Pharmacovigilance for Biologics issued by the 6 Eu2P academic partners
  • Access to a vast Am2P/Eu2P alumni student network

Who is teaching you

Dr Francesco Salvo
Domain coordinator
Université de Bordeaux
Dr Veronique Kugener
Module coordinator and Expert
Takeda
Dr Abimbola Cole
Expert
Takeda
Dr Sepideh Habibi
Expert
CRISPR Therapeutics
Dr Pinak Joshi
Expert
Technical Resources International
Dr Marina Malikova
Expert
Boston University School of Medicine
Dr Maribel Salas
Expert
Daiichi-Sankyo
Prof Bruno Stricker
Expert
Erasmus Universitair Medisch Centrum
Prof Miriam Sturkenboom
Expert
University Medical Center Utrecht
Dr Peggy Webster
Expert
GlaxoSmithKline Research and Development Ltd
Department Of Medical Pharmacology
Reviewers
Université de Bordeaux
Nasop Experts Group
Reviewer
ISoP's North American chapter

What do our trainees say

No alumni testimonials yet

How does it work

  • Start an application file online, providing required academic information
  • You will be granted access to the online course area for a duration of 3 months and will follow the different course activities at your own pace
  • At the end of each course lessons, you will take a quiz exam and should score a minimum of 80% good responses. You should finalize all course lessons and succeed in all lesson quizzes within the 3 months course period to validate your training and be awarded with an academic Post Graduate degree in Pharmacovigilance for Biologics!
  • In case of failure, you can review course activities and retake the final examination quizzes, as long as your 3 months active period is on!

Enrollment

Apply now and get access to the course for 3 months!

Status Base price Reward program* Partner saving*
Student 1,550 € / 1,750 $ up-to -20% -50 %
Professional 3,000 € / 3,500 $ up-to -20% -30 %
Groups Please contact us (price discounts based on group size, partner savings, and reward points)

*possible enrollment discounts are applied in the application cart

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