The Essentials of Pharmacovigilance - 19 June 2019

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.

Who should attend?

This workshop has been designed for anyone who wishes to achieve an understanding of the fundamentals of pharmacovigilance. Especially for newcomers in pharmacovigilance and/or those working in associated areas such as Clinical Operations, Medical Information, Regulatory Affairs etc.

Course Objectives

• 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

Topics

• Definitions and legal background
• Sources of cases
• MedDRA - hands on
• Case processing
• Demonstration of an E2B(R3) compliant database

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:

19 June 2019

Time:

09.00 – 17.00 hrs

Venue:

CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Directions:

Tram 15
Tram stop «Grosspeterstrasse»

Fee:

Registration Fee: CHF 950.00 + 7.7% VAT
10 % reduction for CTC employees, SwAPP and SBA members.
special rates available for PhD Students, please contact training@ctcresourcing.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.

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:

Essentials of PV_Flyer.pdf

Training Terms & Conditions