Essentials of Pharmacovigilance
June 10 @ 9:00 am - 5:00 pm CEST
The purpose of this workshop is to create an understanding of the key aspects of Pharmacovigilance (PV). It will provide an overview and introduction to the definitions such as sources of cases, MedDRA (Medical Dictionary for Regulatory Activities) coding, case processing, and a first glance at a PV database. It is designed for anyone who wishes to achieve an understanding of the essentials of pharmacovigilance.
- Get a grasp on essential definitions of PV
- Learn a good approach to MedDRA coding
- Understand the origin of cases and how to determine their validity
- Learn to distinguish between solicited and unsolicited cases
- Develop case assessment and processing skills
- Gain a first impression of a PV database
- Definitions and legal background
- Sources of cases
- MedDRA – hands on
- Case processing
- Demonstration of an E2B(R3) compliant database
Who should attend?
This workshop has been designed for anyone who wishes to achieve an understanding of the essentials of pharmacovigilance. Especially for newcomers in pharmacovigilance and/or those working in associated areas such as Clinical Operations, Medical Information, Regulatory, Affairs etc.
Dr. med. Susanne Kienzle-Horn, Senior Consultant, SCRATCH Pharmacovigilance GmbH, Germany
studied medicine and informatics and started working in the pharmaceutical industry in 1990. In addition to her more than 25 years of PV experience resulting from practical work in this area, she has wide-ranging soft skills in areas like leadership, training and coaching. She is the founder of SCRATCH Pharmacovigilance GmbH, a service provider who supports, advises and trains pharmaceutical entities in Europe in all areas of pharmacovigilance.
Magnus Lühring, PV Training Specialist, SCRATCH Pharmacovigilance GmbH, Germany
started to work for SCRATCH Pharmacovigilance in 2005, directly after having completed his professional education as ‘Medizinischer Dokumentar’ (medical documentalist). His focus lies on ICSR processing in several PV databases, ICSR submissions to regulatory authorities, XEVMPD product maintenance, as well as lecturing and co-lecturing of PV seminars and MedDRA workshops. Since 2009, he is a “Certified MedDRA Coder” and, since 2014, he bears the title of “TÜV Certified PV Manager”.
Interactive sessions with a mix of lectures, hands on training and knowledge transfer, case studies to illustrate theory, exercises to gain first experience and test the knowledge, group work, & Q&A sessions.
This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).
Registration Fee: CHF 950.00 + 7.7% VAT
15 % reduction for SwAPP and SBA members
Special fees for CTC employees
Special rates available for PhD Students, please contact email@example.com
The fee includes course documentation, refreshments, lunch and a course participation certificate
Payment: After registration, you will receive confirmation and an invoice with instructions on how to complete the bank transfer. Full prepayment is needed prior to the course.
• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
In case of no show, no refund will be made.