Pharmaceutical Contracts: GMP and Legal Compliance & pre-course session Contracting in China
Speakers
Dr Carsten Coors, form.Vetter Pharma-Fertigung GmbH
Silke Mainka, Lawyer and Legal Counsel, Law Firm Mainka
Dr Rainer Gnibl, EU-GMP Inspector, Local 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.
The pre-course session is dealing with general and particular aspects when contracting in China.
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
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?
- 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
- Confidentiality agreement
- Technical/Quality Agreement
- Supply Agreement
- Other Agreements
- Their structure and how they fit together within the supply chain
- 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
- 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)
- Who is involved
- Helpful terms and arrangements
- Demands and challenges
- Quality agreements during development
- Economic limits
- Minimum content
- Who is involved?
- Helpful terms and arrangements
- Perception and supervision of agreed responsibilities
- Implementation of contractual obligations into company GMP system
- 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.
Programme pre-course Session “Contracting in China”
Legal Background
- Chinese law and jurisdiction
- General terms and conditions
- Applicable law
- Contract negotiation
- Contractual clauses
- Stipulation
- Language
- Signatures
- Possible pitfalls
- Practical experience
- Possibilities
- Strategy
- Costs
- Trade secrets
- Ownership and filing for IP rights
- Confidentiality agreements
- Enforceability
- Place of jurisdiction
- Conduct of a case in China
- Arbitration
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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