Pharmaceutical Contracts: GMP and Legal Compliance

Pharmaceutical Contracts: GMP and Legal Compliance

Barcelona, Spain

Course No 9069


Costs

This conference already took place.

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

Speakers

Dr Carsten Coors, Qualified Person, Vetter Pharma-Fertigung GmbH
Silke Mainka, Lawyer, Pharmaceutical Industry
Dr Rainer Gnibl, EU-GMP Inspector, Bavarian Government
Dr Thomas Pattloch, Lawyer, Taylor Wessing

Objectives

Three prerequisites are needed to work out contracts which are legally and GMP compliant:
Awareness of the GMP requirements
Applicable legal and juristic knowledge
The practical perspective.
During this course you will learn how to cover all these relevant aspects.

Background

Not only caused by increasing contract manufacture and analysis, every pharmaceutical company establishes business connexions with a number of suppliers and
service providers worldwide. The regulating authorities call for correctly defined, agreed and controlled contracted services. The EU-GMP Guide and international legislation require a written contract between the partners which clearly establishes the duties and responsibilities of each party.

By compiling these contracts it is of extreme importance not only to meet the legal expectations. The company and the responsible persons need to be aware of their tasks and their liability. Not to mention that the contents should be easily transferable into the daily work and must be reduced to practice.

The speakers in this education course have a substantial knowledge in the design and implementation of
contracts in the pharmaceutical industry.

You will get first hand practical information.

Target Group

This course and its pre-session are designed for all
personnel involved in the realisation of contracts. It also applies to decision makers and responsible persons who must implement the subject matters of the contract. The course is addressed to both the contract giver and the contract acceptor.

Free contract examples:

Every participant of the 2-day Education Course will get a CD with various contract examples:

Agreement on Contract Manufacturing of
-Medicinal Products
-Medical Devices
-Foodstuffs
Contract Testing of Medicinal Products
Agreement on Quality Assurance concerning
-Starting Materials
-Transport of Medicinal Products

Prepared by the German Medicines Manufacturers’ Association (BAH)

Programme

GMP Requirements and Expectations of the Regulatory Authority
Outsourcing of activities
Which external activities require Technical/Quality Agreements?
Regulatory requirements and legal basis
How to create a Technical/Quality Agreement
Quality Agreement essential for QP and QA?

International Law:
basic juristic Knowledge for responsible Functions
International laws and systems – how they work and fit together
Jurisdictions and conflict of law provisions
Contract law
Jurisdictions law
General product liability concepts
Case studies

Agreements – the legal Perspective
Confidentiality agreement
Technical/Quality Agreement
Supply Agreement
Other Agreements
Their structure and how they fit together within the supply chain

Design and Layout of Contracts –
Evaluation of the Content
Basic principles – contractual obligations and responsibilities towards third parties
Contents of agreements
Definitions
Timelines and Targets
Loss of Products
Intellectual Property
Assignment
Term and Termination
Arbitration
Practical examples

Pharmaceutical Contracts in the Light of Inspections
Frequent findings
Business contract vs. Technical/Quality Agreement
Table of content
Clear responsibilities
Product life cycle and Technical/Quality Agreement
Internal contracts?
Evaluation of a Technical Agreement
(interactive session)

The GMP Technical Agreement/ Quality Agreement
Who is involved
Helpful terms and arrangements
Demands and challenges
Quality agreements during development
Economic limits

The Delineation of pharmaceutical Responsibilities and the mutually agreed Specifications
Minimum content
Who is involved?
Helpful terms and arrangements
Perception and supervision of agreed responsibilities
Implementation of contractual obligations into company GMP system

Supply and Service Agreements:
what you need to know
Practical aspects you need to consider when
establishing contracts with
Suppliers of excipients and packaging materials
Service providers (e.g. clothing, pest control)

Workshop
Evaluate given contract examples and case studies from various points of view and discuss them with the speakers.

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