1 to 5 February 2016: This 5-day course will cover European clinical pre and post-marketing safety regulatory requirements.
About the training
As well as providing a firm grounding on key aspects of global and European clinical pre-and-post-marketing safety regulatory requirements, the course covers updates on pharmacovigilance legislation. It also covers the latest news on the international harmonisation and standardisation activities in pharmacovigilance.
See more information about the course and register .
The key topics include:
- definitions and methods in pharmacovigilance
- regulatory aspects in pharmacovigilance and practical examples
- diagnosis and management of adverse drug reactions
- signal detection and signal management
- risk management
Who should attend
The course, delivered by the Medicines and Healthcare products Regulatory Agency (MHRA) and Develop Innovate Advance (DIA), is for professionals involved in pharmacovigilance and qualified persons for pharmacovigilance (EU QPPV) as well as those involved in:
- clinical research, regulatory affairs, risk management
- medical product safety assessment
- data analysis, epidemiology, labelling
- quality assurance, compliance, medical information
Date and location
1 to 5 February 2016
Holiday Inn London - Regent's Park
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom has accredited this training course with 32 CPD credits.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 32 credits.
Published: 18 December 2015