David Cockburn, formerly European Medicines Agency (EMA)
Dr Susanne Ding, Boehringer Ingelheim
Dr Rainer Gnibl, EU-GMP Inspectorate
Dr Ulrich Kissel, European QP Association
Dr Bernd Renger, Past Chair of the 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 is becoming more global due to international collaborations, mergers and acquisitions and more complex supply chains requiring 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, recognizing this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the European 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. Various case studies will be presented and discussed to come up with possible solutions.
Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking.
I would like to invite you to this unique opportunity, and I look forward to meeting you.
Richard M. Bonner
Chairman of the European Qualified Person Association
The Conference has been designed for non-EU QA and QCU personnel, upper management functions and authority representatives who want to be informed about the latest development regarding European GMPs and the duties and responsibilities of Qualified Persons.
The presentations of this conference will be available for download and your print-out 1 week before the conference. You will also receive a USB stick at the conference’s registration desk.
Note: there will be no print-outs available during the conference.
Introduction: The ECA and the European QP AssociationEU legal order and relevant guidelines (overview)
EU Manufacturing Authorisation & EU-GMP Certificate
Non-compliance with EU-GMP and authority actions
MRA: Technical terms
Exchange on GMP-information between US and EU
MRA impact for industry
Are inspections no longer required?
Are audits no longer required?
EU-GMP/GDP Update - what’s going on at the Moment
Part 1: Understand European GMPs
The EU Pharmaceutical GMP-/GDP Legislation & Facts on the Mutual Recognition
15 Years Development of EU GMPs and the Impact to the QP
- The Current EU GMP Revisions and their consequences
- A brief look on the EU GDP requirements
- Challenges with differing FDA expectations
Import of Medicinal Products and APIs into the European Union
- How things evolved
- The well-established European concept of the QP
- Future developments and the US-EU co-operation
- What EU expects from US companies
The new EU Lifecycle Approach on Process Validation vs. the US-Approach
- Differences between originating countries
- 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 to
- Procedure if a non-EU company imports to different EU Member States
- Difference in US & EU Wording
- Comparison of validation stages – different, comparable or equal?
- Comparison US APR & EU PQR and how to synchronize
- What about Product Quality Reviews of APIs in US & EU?
Part 2: Understand the Role of the QP
The Legal and Professional Duties of the Qualified Person
QP Duties and Responsibilities – individual Member States’ Regulations
- The role of the QP within the pharmaceutical quality System
- The differences between ICH Q10 and the US Quality Systems Guidance
- What the QP is responsible for
- Batch certification and release for the EU Market
- The Role of the QP in Contract Manufacturing and Testing
- Comparison between the responsibilities of the Head of the US QCU and the EU QP
- Is there something like a US based QP?
Annex 16 and the Release of Batches by the QP
- The different Transformation of Directive 2001/ 83 into national laws
- Article 49 (2) – “minimum conditions of qualification”
- Article 50 – “established rights and responsibilities”
- Continual professional development
- The role of professional bodies in the various member states
- Selected examples
The role of the QP in the Supply Chain and Supplier Qualification
- European and national Guidance and Expectations on investigating Deviations and OOS Results
- Responsibilities of the QP
- The QP’s true margin of discretion when releasing batches with deviations
- Selected examples
- QP Declaration
- Supply Chain oversight and supply chain diagram
- EU Inspections and company audits in the U.S. and the Involvement of the QP
Part 3: Clinical Trial Supplies
Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP
- Current and future EU-GMP and QP requirements for the release of Investigational Medicinal Products (IMPs)
- Specific aspects of IMP supply chains
- GMP-GCP Interface
- QP oversight and being a QP in a global environment