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
- 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)
Case Studies: Evaluation of Contract Examples and Cases
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
Every participant will get 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).