Dr Carsten Coors, Vetter Development Services Austria
Dr Rainer Gnibl, EU-GMP Inspector, Local Government
Silke Mainka, Lawyer and Legal Counsel
Three prerequisites are needed to work out contracts which are legally and GMP compliant:
- wareness 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.
Not only caused by increasing contract manufacturing 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 substantial knowledge in the design and implementation of contracts in the pharmaceutical industry.
You will get first hand practical information.
This 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?
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
- Timelines and Targets
- Loss of Products
- Intellectual Property
- Term and Termination
- 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)
Evaluate given contract examples and case studies from various points of view and discuss them with the speakers