Course Overview

Language – This course will be given entirely in German – Read the Course Content In German

International pharmaceutical laws, regulations and guidance change at a frightening pace – it’s difficult to keep up!  That’s why we have developed this one-day “refresher” course for you.  We keep track of all the changes so you don’t have to – just come along and learn what’s new and what’s on the horizon. Ideal CPD for the busy Qualified Person or pharmaceutical quality professional.

About This Course

The QA Manager and other technical/managerial personnel need to be informed and aware of pharmaceutical legislation. Changes in legislation and guidelines, and the interpretation of them, can have significant implications for the individual and their company.

The amount of change is currently at an unprecedented level, however, being unaware of new requirements is no excuse for non-compliance.

This is the continuation of a very successful series of one-day seminars that are designed to form part of your Continuing Professional Development.

What You Will Learn

The current interpretation of recent and proposed changes to:

  • EU legislation – Directives and Regulations
  • EU GMP – Chapters and Annexes
  • International guidance
    • ICH, PIC/S, WHO
  • US legislation and FDA guidance

Course Tutor

Martin Kloemkes

Martin Kloemkes has over 25 years’ experience in the pharmaceutical industry, working with Boehringer Ingelheim and Johnson & Johnson in Germany, the US and Switzerland. He has held positions as Global Non-Clinical and Chem-Pharm Project leader in the development of new drugs, as team leader in Quality Management of marketed drugs, within the Competitive Intelligence arena and more recently in Regulatory Affairs.

His areas of expertise include:

  • Pharmaceutical R&D
  • Capacity management
  • Quality management
  • Life-cycle management
  • Regulatory affairs
  • Control of change management
  • Leadership of international multi-disciplinary teams

Martin holds a PhD in Biochemistry from the Technical University of Aachen (Germany) and a MBA in Strategic Management from the State University of New York at Albany.