GET A VALUABLE CERTIFICATE FOR JOB MARKET


ACADEMIC RECOGNITION OF 3 OR 6 CREDITS


DESIGNED FOR EXPERTS BY EXPERTS


BENEFIT RISK ASSESSMENT


Eu2P Certificate: Benefit Risk Assessment

OBJECTIVES

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. The different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations.
  2. Insight in the changing health care environment and gives an overview of the different stakeholders that are involved in pharmacotherapeutic decision-making. Specific attention is given to the drivers and background of the different stakeholders and the rationale of benefit/risk and pharmacoeconomic evaluations in decision-making
  3. An overview and to define the concepts necessary to built a risk management plan for medicinal product.
  4. Define the general principles needed to build a process for developing Risk Management Plans for a medicinal product by the Industry. This course is based on the experience of a large international pharmaceutical company.
  5. An introduction to REMS principles, content, implementation, reporting and assessment, When a REMS is required and the Differences between REMS and RMP

qualitative frameworks, quantitative methods, BR assessment, HC environnement, decision-making, RMP, REMS, FDA, Risk Management Plans, Benefit/risk, decision-making

 

MODULE PARTS

  1. Benefit-risk assessment of medicines
  2. Risk Management

 

TRAINER TEAM

Coordinator: Dr Veronique Kugener (from Takeda)

Expert(s): Dr Katia Verhamme (from Erasmus Universitair Medisch Centrum), Prof Olaf Klungel, Prof Hubert Leufkens (from Universiteit Utrecht), Dr George Quartey (from F. Hoffmann-La Roche Ltd), Dr Laurent Auclert (from Sanofi-aventis Recherche et Développement), Prof Annalisa Capuano (from Università degli Studi della Campania Luigi Vanvitelli), Dr John Price (Independent), Nasop Experts Group (from ISoP's North American chapter), (from Takeda).

Intermediate level
75 h workload over 3 months (3 ECTS credits)
Key dates
Course calendar
Certificate award
or included in PhD or PhD programme
English language
Online based learning
Student :
1,500 € / $1,750
Professional :
3,000 € / $3,500
  Savings could be offered under eligibility conditions.

APPLY NOW

Applications open until December 12th, 2021

Or include this module in your training curriculum choices...

PhD



Confused? Read the FAQs...

NEED TO TALK TO US?

+33 6 30 29 00 29

Monday-Friday / 9.00am-6.00pm CET

 

Powered By

Eu2P Executive Board partners

Created By

Eu2P project consortium partners