Pharmaceutical Contracts: GMP and Legal Compliance

Pharmaceutical Contracts: GMP and Legal Compliance

Vienna, Austria

Course No 21528

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager". Learn more.

 

Our Service

Costs

Non ECA Member*: EUR 1890,--

(All prices excl. VAT). Important notes on sales tax.

Registration
* 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

Dr Carsten Coors, Vetter Development Services Austria
Dr Rainer Gnibl, EU-GMP Inspector, Local Government, Germany
Dr Monika Hupfauf, NOMOS Attorneys-at Law, Austria

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 training course you will learn how to cover all these relevant aspects.

Background

Not only caused by increasing contract manufacturing and analysis, every pharmaceutical company establishes business connexions with a number of manufacturers, 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 substantial knowledge in the design and implementation of contracts in the pharmaceutical industry.

You will get first hand practical information.

Target Group

This training course is 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.

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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
  • Is a Quality Agreement essential for QP and QA?
What QA needs to know about juristic Principles
  • Basic juristic knowledge for responsible functions
    - International laws and systems – how they work and fit together
    - Common Law vs. Civil Law
    - International business: which law applies in the contract?
  • Contract law
  • Responsibilities within the company (who is signing what)
  • What to do in the case of mergers and Acquisitions
  • Contracts with several entities within the same group of companies
  • Case studies
Different Agreements in pharmaceutical Industry
  • Confidentiality Agreements
  • Research and Development (F&E) Agreements
  • Master Service Agreements
  • Clinical Trial Agreements
  • Manufacturing and Supply Agreements
  • Technical/Quality Agreements
  • Distribution Agreements
  • Their structure and how they fit together within the supply chain
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)
Interactive Session: Evaluation of Contract Examples and Cases
  • Principles
  • Structure
  • Content

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