David Cockburn, form. European Medicines Agency (EMA)
Dr Susanne Ding, Boehringer Ingelheim
Dr Rainer Gnibl, EU-GMP Inspectorate
Dr Ulrich Kissel, European QP Association
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.
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.
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.
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 Part 1: Understand European GMPs | 11 – 12 July 2023
The EU Pharmaceutical Legislation and the respective Inspection System
- EU legislation and relevant guidance documents (overview)
- The EU inspection System
- Non-compliance with EU-GMP and authority Actions
- EU Manufacturing Authorisation & EU-GMP Certificate
- MRA: impact for Industry
- Exchange on GMP-information between US and EU
Export and Import of Medical Products
- Annex 21 of the EU-GMP Guidelines
- Import of Medicinal Products and APIs into the European Union
- Which types of materials do fall under EU import legislation?
- Regulatory requirements for Import
- Which documents are needed for import activities of medicinal products and APIs
- Regulatory procedure to get an import Licence
- Procedure if a non-EU company imports to different EU Member States
The Role and Responsibilities of the QP
- Batch certification and release for the EU Market
- Directive 2001/83/EC; Article 49 – “conditions of qualification”
- Annex 16 of the EU-GMP Guidelines
- The role of the QP within the pharmaceutical quality System
- What the QP is responsible for
- The QP’s margin of discretion when certifying batches with deviations
- Supply Chain oversight and supply chain diagram
- QP Declaration
Distribution in the EU
- GDP requirements
- Importers, brokers, local affiliates, pre-wholesalers, wholesalers, parallel Import
- Virtual companies
Brexit: Consequences for the pharmaceutical Industry
- UK and EU Point of View
- The Northern Ireland Protocol
- Impact on the roles and responsibilities of the QP
- What companies outside Europe need to be aware of
- Examples of complications
When things go wrong
- Complaint and recall handing
- The QP and the QPPV
- When to contact the authorities
Programme Part 2: Clinical Trial Supplies (optional) | 13 July 2023
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
Question and Answer Sessions
When attending live online, a set of live Q&A Sessions will give you the possibility to interact with the Speakers and get answers to your questions.