Basics of Pharmacovigilance Post Authorisation - 10 April 2019

The purpose of this workshop is to introduce Pharmacovigilance (PV) in Post Authorisation. It will provide essential background knowledge on the origin of PV, sources for cases, case assessments in post authorisation, special situations, quality complaints, and case submissions

Who should attend?

This workshop has been designed for anyone who wishes to get an overview of pharmacovigilance in the post authorisation phase. Especially for newcomers in post authorisation pharmacovigilance and/or those working in associated areas such as Regulatory Affairs, Medical Information etc.

Course Objectives

• Understand the origin of cases and how to determine their validity
• Learn to distinguish between solicited and unsolicited cases
• Develop a comprehension of case assessments
• Learn how to deal with 'special situations'
• Gain a first impression of how to submit a case

Topics

• Sources of cases
• Case assessments post authorisation
• Special situations and quality complaints
• Case submissions

Course Leaders

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'.

Learning Methodology

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.

Date:

10 April 2019
If you are also interested in attending workshop I, please contact training@ctcresourcing.com

Time:

09.00 – 17.00 hrs

Venue:

CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Directions:

Tram 15
Tram stop «Grosspeterstrasse»

Fee:

Early Bird Fee: CHF 990.00 + 7.7% VAT (valid until: 27.02.2019)
Regular Fee: CHF 1'100.00 + 7.7% VAT (valid after: 27.02.2019)
10 % reduction for CTC employees and members of SwAPP and SBA.
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.

Cancellation Policy:

• 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.

Document:

Basics of PV Post Authorisation_Flyer.pdf

Training Terms & Conditions