European GMPs and the Role of the Qualified Person (QP): Clinical Trial Supplies (Day 3 only) – Live Online Training

European GMPs and the Role of the Qualified Person (QP): Clinical Trial Supplies (Day 3 only) – Live Online Training

Course No 20662

All times mentioned are CEST.

Costs

ECA-Member*: EUR 590,--
Regular Fee*: EUR 790,--
EU/GMP Inspectorates*: EUR 395,--
QP Member Discount*: EUR 590,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

David Cockburn, form. European Medicines Agency (EMA)
Dr Susanne Ding, Boehringer Ingelheim
Dr Rainer Gnibl, EU-GMP Inspectorate
Dr Ulrich Kissel, European QP Association

Objectives

This event is designed by QPs and international Experts as a forum with focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP’s daily work.

Background

The Pharmaceutical Industry has become more global due to international collaborations, mergers and acquisitions and more complex supply chains require companies to have a greater understanding of pharmaceutical legislation throughout the world. This is becoming increasingly evident by the number of non-EU professionals contacting the European Compliance Academy and the Qualified Persons Association asking for more and more detailed information about the European GMPs and the unique role and responsibility of the EU QP.

The ECA Academy and the European QP Association, recognising this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the EU approach and legal framework in this respect. Therefore, the QP Association has set up the programme at hand on European GMP requirements and the role of the QP.

In light of the establishment of a Mutual Recognition Agreement between US and EU and the parallel move out of Great Britain from the EU, representatives from the authorities as well as QPs and well-known experts will talk about the current issues and share their point of view.

Target Group

The Conference has been designed for non-EU QA and QCU personnel, upper management functions and authority representatives who want to be informed about European GMPs and the duties and responsibilities of Qualified Persons.

Technical Requirements

We use Webex Events for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP
  • Current and future EU-GMP and QP requirements
  • Certification and release of Investigational Medicinal Products (IMPs) for studies in the EU
  • Specific aspects of IMP supply chains
  • GMP-GCP Interface
  • QP oversight and being a QP in a global environment

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