Pharmacovigilance © © Paulista


Pharmacovigilance covers the safety and risk issues one must address to ensure patients receive safe drugs. This course will give students a working knowledge of all aspects of drug safety monitoring and risk management, enable them to predict and analyse drug interactions and recognise the implications for prescribing and product licence. The student will also be familiar with pharmacovigilance best practice, including monitoring strategies and action plans, and will be fully cognisant of regulatory reporting requirements. At the end of the course, students should be able to:

- Appreciate the effect on patient safety and on a product licence of the different types of adverse events/reactions

- Identify the key safety reporting requirements, according to the type of adverse event/reaction, in clinical research or in commercial products

- Construct and evaluate benefit/risk assessments throughout the life cycle of a medicine, with reference, where applicable, to issues around pre and post- market authorization

More information


• Introduction to Pharmacovigilance

• Background and Legislative Framework

• Drug Safety Reporting

• Translational Safety

• Pharmacoepidemiology and Signal Evaluation

• B-R (Benefit-Risk) Assessment

• Risk Management Planning

• Regulatory Actions to Protect Patient Safety

• Communication of Safety Issues

• Crisis Management

• Future Challenges and Advances in Pharmacovigilance

Contact | Information material

For further information about our in-house seminars, company terms and conditions or questions regarding our content please get in touch with us via email, phone or the contact form. We would also be pleased to send you our 'Offers for companies' information brochure. We look forward to hearing from you.

Merlet Behncke-Braunbeck
Director Distance Learning
Tel.:  +49 (0) 6221 487 8061

Please contact me directly or use the quick & easy 
Contact form for corporate customers

Date | Price | Audience


Self-guided learning

Co-operation partner: 

Healthcare Learning

Duration| Workload | Certificate: 

8 weeks | 30 hours of tutor guided learning activities | Certificate of completion by Healthcare Learning




€ 1.000,- (plus VAT)




Companies can book this course for their employees directly at Springer Campus. If you are an employee of a company and would like to take this course, please contact your HR department so that they can book the course for you at Springer Campus.   

AGB              Zurück zur Übersichtsseite