This 5-day course covers key aspects of global and 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.
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 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
28 September to 2 October 2015
Holiday Inn Kensington Forum Hotel
Alternatively you can return the paper form by email to email@example.com or fax +41 61 225 51 52.
According to the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom you are eligible for 25 CPD credits with this course.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 32 credits.
Published: 25 August 2015