Basic Pharmacovigilance and Pharmacovigilance Regulations

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

  •  Degree
  •  3 ects workload
  •  Introductory level

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. The requirements for Pharmacovigilance in the United States as compared to the ones in the European Union, for Pre-approval and Post-approval and the imminent changes in the European Union and in the United States
  2. The legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice
  3. The safety communication processes and the safety risk management approach, including the safety label change process
  4. The principles of prescription drug labeling in the United States, the FDA requirements for prescribed drug labels and the United States Prescribing Information (USPI)
  5. The analysis of the safety profile of any medicine which should weight up the consequences of a given adverse drug reaction to individual patients exposed to the medicine, as well as the impact on the community

What will you learn

At the end of this module, the successful trainees should be able to

  • Understand pharmacovigilance regulations and guidelines in the US as related to EU legislation and guidance
  • Understand the legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice.
  • Understand the principles of drug labeling, FDA regulations related to the label and description of USPI
  • Understand the different risk estimates and its application to estimate the potential impact of an ADR at a community level, including the NNH, the importance of consumption data to estimate the potential impact of an ADR at a community level and the practical application of these calculations
  • Know about aggregate reports, including Periodic Adverse Drug Experience Reports (PADERs) and Periodic Adverse Experience Reports (PAERs), as well as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs) as applicable to FDA requirements

What’s included

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

What's the course content

US-EU Regulations: principles and comparison

US-EU Regulations: principles and comparison

  •  Award
  •  180 min
Overview of the Legal Basis of PV Regulations and the Role of the QPPV

Overview of the Legal Basis of PV Regulations and the Role of the QPPV

  •  Award
  •  180 min
Principles of Labeling and Description of United States Prescribing Information (USPI)

Principles of Labeling and Description of United States Prescribing Information (USPI)

  •  Award
  •  180 min
Pharmacovigilance in Combination Products and Regulations

Pharmacovigilance in Combination Products and Regulations

  •  Award
  •  180 min
From individual cases to the community impact of adverse drug reactions: measuring tools

From individual cases to the community impact of adverse drug reactions: measuring tools

  •  Award
  •  120 min
Aggregate reporting in the US

Aggregate reporting in the US

  •  Award
  •  150 min

Who is teaching you

Prof Albert Figueras

World Health Organization
Dr Sherael Webley

University of Hertfordshire
Dr Veronique Kugener

Takeda
Dr Marina Malikova

Boston University School of Medicine
Dr John Price

Independant
Dr Maribel Salas

Daiichi-Sankyo
Dr Abimbola Cole

Takeda
Nasop Experts Group

ISoP's North American chapter

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 Basic Pharmacovigilance and Pharmacovigilance Regulations!
  • 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 1,500 € / 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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