Pharmacovigilance: Global regulations (English)

Our Good Pharmacovigilance Practice (GPV) online training platform allows you to access our courses from wherever you are. Get trained and certified at your convenience. If you are involved in any aspect of pharmacovigilance (GPV), our four course modules will help you comply with European & US law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory and quality compliance. If you would like to strengthen your pharmacovigilance knowledge then this course will help you comply with global regulatory requirements, which state that you must have a good understanding of the principles and guidelines within pharmacovigilance. The Pharmacovigilance Global Regulatory Requirements course is perfect for you if you are involved in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and is a great addition to your knowledge in pharmacovigilance when combined with the Overview of Pharmacovigilance & Drug Safety course. The course contains interactive mini-exams at the end of each chapter to help reinforce learning.

The Pharmacovigilance Global Regulatory Requirements course covers the key components of US and EU legislation, US and EU safety reporting regulations, including publications by the Council for International Organizations of Medical Sciences (CIOMS) and guidelines from the International Conference on Harmonisation (ICH). The course delivers an explanation to the global regulatory requirements of pharmacovigilance and thoroughly explains the regulatory issues across global government agencies that improve safety across international markets. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge of the global legislation attributed with pharmacovigilance and drug safety.