Pharmaceutical Contracts: GMP and Legal Compliance
6/7 March 2025, Vienna, Austria
Course No. 21528
Speakers
Dr. Carsten Coors
Vetter Development Services Austria
Dr. Monika Hupfauf
Attorney-at Law, Austria
Dr Rainer Gnibl
GMP Inspector
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.
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
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
Testimonials
Seminar Programme as PDF