Basics of Pharmacovigilance in Clinical Trials - 9 April 2019
This workshop is designed to provide a solid foundation of Pharmacovigilance (PV) in Clinical Trials. It will introduce the most important terms and definitions, MedDRA (Medical Dictionary for Regulatory Activities) coding, SAE (Serious Adverse Event) management, unblinding processes, SUSAR (Suspected Unexpected Serious Adverse Reaction) submission, and a first glance at a PV database.
Who should attend?
This workshop has been designed for anyone who wishes to get an overview of basic pharmacovigilance in clinical trials. Especially for newcomers in clinical trial pharmacovigilance and/or those working in the pharmaceutical or CRO industry in clinical research.
• Get a grasp on essential definitions of PV in clinical trials
• Learn a good approach to MedDRA coding
• Explain the pathway from a SAE to a SUSAR
• Gain a first impression of how a PV database could look like
• MedDRA - hands on
• From SAE to SUSAR, including unblinding procedures and submissions
• Demonstrations of an E2B(R3) compliant database
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 working for the company 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 anc 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 lecture, hands on training and knowledge transfer, case studies to illustrate theory, exercises to gain first experience and test the knowledge, group work and Q&A sessions.
9 April 2019
If you are also interested in attending workshop II, please contact email@example.com
09.00 – 17.00 hrs
Tram stop «Grosspeterstrasse»
Early Bird Fee: CHF 990.00 + 7.7% VAT (valid until: 26.02.2019)
Regular Fee: CHF 1'100.00 + 7.7% VAT (valid after: 26.02.2019)
10 % reduction for CTC employees, SwAPP and SBA members.
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.
Training Terms & Conditions