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Course No 7866

The Bridge to European GMPs and the Role of the Qualified Person (QP)

, San Francisco, CA

Non-ECA Members: USD 2.100,--
ECA Members: USD 1.990,--
Government/Health Authorities: USD 750,--
(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:
The Bridge to European GMPs and the Role of the Qualified Person (QP)

Richard M. Bonner, Chairman of the European QP Association
Dr Rainer Gnibl, EU-GMP Inspectorate, Germany
Tor Gråberg, Medical Products Agency, Sweden
Dr Bernd Renger, Immediate Past Chair of the European QP Association, Germany
Martine Tratsaert, Johnson & Johnson, Belgium
Mark Tucker, Ph.D, form. FDA Investigator and Compliance Officer, USA

Over the past few years the role and duties of the Qualified Person keep
increasing in significance and scope. Being the key person in the quality
function of a pharmaceutical company, the QP has to consider many
issues to fulfil the responsibilities and to comply with the European

This Conference 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 patent of several key block busters is going to expire in the next few years. The success of generic introduction is significantly depending on time to market and proper development and successful regulatory submission. Despite of the achieved international harmonisation there are still significant differences between the regulatory environment of generic s in the US and Europe.
In October 2012 the new Generic Drug User Fee Act (GDUFA) came into force. Generic companies and API manufacturers have now to cope with an additional fee burden when trying to get FDA’s approval for marketing Generics in the US.
It is therefore necessary for a globally acting generic industry to consider the key aspects for regulatory procedure properly.

Introduction: The ECA Foundation and the European QP Association
Richard M. Bonner

Part I: Understand European GMPs

The European Pharmaceutical Legislation
Relevant European Pharma- and GMP-regulation
Prerequisites for EU GMP-compliance
Agreements between EU and third countries (MRA) and impact on USA
Exchange of information between competent EU-authorities (EMA compilations of community procedures) and impact on USA

Plus: EU-GMP Update - what’s going on at the Moment

The View of the FDA
What does FDA think about the EU QP
Differences between ICH Q 10 and the US Quality Systems Guidance: why both guidances are out in parallel in the US
EMA and FDA authority positions with respect to the differing GMPs and role of the QP

Case Study: How we experienced EU GMPs and how we align our Quality Systems
US GMPs versus EU GMPs
Responsibilities of Head of the Production and the Head of Quality Control
How to implement policies that will be compliant for EU and US GMPs
How to certify a batch for the EU market

Import into European Union:
Preconditions and GMP-certificate/ MIA
Requirements for different materials or products
Who is allowed to import
Which documents are needed for import
How to obtain a GMP-certificate (GMP-compliance)
How to prepare an EU GMP-inspection
Inspection-procedure and follow-up
Procedure from applicants import request till placing on the EU-market

The Role of PIC/S in a globalising World
PIC and the PIC Scheme
Current and future activities
USA as PIC/S member: benefits and challenges

Part II: Understand the Role of the QP

The Legal and Professional Duties of the Qualified Person
The role of the QP within the pharmaceutical quality System
The differences between ICH Q 10 and the US Quality Systems Guidance
What the QP is responsible for
Batch certification – how is it done?
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?

QP Duties and Responsibilities – individual Member States’ Regulations
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 EU Discretion Paper and the Release of Batches by the QP
European and national Guidance and Expectations on investigating Deviations and OOS Results
Responsibilities of the QP
The EMA Reflection paper on “QP Discretion”
The QP’s true margin of discretion when releasing batches with deviations
Selected examples

EU-PQR versus US-APR
Goals and technical-terms of EU-PQR
Critical points
Practical implementation of EU-PQR
Comparison between EU- and US-requirements
PQR and contract manufacturing

The role of the QP in the Supply Chain and Supplier Qualification
Proposal to have the QP sign a declaration that the supply chain is secure
Supply Chain oversight
EU Inspections in the U.S. and the Involvement of the QP

The US Quality Unit versus the EU QP (Panel Discussion)

Clinical Trial Supplies: IMP Handling in Europe and the Role
of the QP
EU GMP and QP requirements for the release of Investigational Medicinal Products
GMP-GCP Interface
QP oversight and being a QP in a global environment
Liability of the IMP QP
Case studies

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