Personnel involved in the preparation and implementation of contracts
Decision makers and responsible persons
Contract giver and contract acceptor
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.
Moderator Mr Wolfgang Schmitt, Concept Heidelberg (on behalf of ECA)
Programme
GMP-Requirements and Expectations of the Regulatory Authority
Outsourcing of activities
Legal basis for technical agreements
Regulatory requirements for technical agreements
How to create a technical agreement
Technical agreements essential for QP and QA?
What about US FDA?
What QA needs to know about Legal 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 the 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
Common GMP/GDP requirements
Clear responsibilities
Commercial contract vs. technical agreement
Technical agreement management
Table of contents
Product life cycle & technical agreement
Internal contracts
Frequent findings
Challenge supply chain complexity
Chain of contracts
The GMP Technical Agreement/ Quality Agreement
Purpose and pre-requisites
Structure and main elements
Development Quality Agreement
Compliance with marketing authorization and GMP
Do’s and don’ts
The Delineation of pharmaceutical Responsibilities and the mutually agreed Specifications
Pre-requisites
How to deal with specifications
Delineation of pharmaceutical responsibilities: the “tick list”
Deviations and Changes
What about pharmaceutical development?
Supply and Service Agreements: what you need to know
Scope
Categorisation of material supplier and service supplier
Principal considerations
Examples: Pest Control, Packaging Material, Excipient
Example: “Chain of contracts“, “QP-QP Arrangement”
Interactive Session: Evaluation of Contract Examples and Cases
Principles
Structure
Content
Question and Answer Sessions A set of Q&A sessions will give you the possibility to interact with the speakers and other participants to get answers to your questions.
Further Information
Venue DoubleTree by Hilton Berlin Ku´Damm Los-Angeles-Platz 1 10789 Berlin, Germany +49 30 2127 714 info@doubletreeberlinkudamm.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG after registering for the course. Reservations should be made directly with the hotel. Early booking is recommended.
Social Event On 4 May, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on-site and that there will not be any opportunity to print the presentations on-site.After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Fees (per delegate plus VAT) ECA Members EUR 1,890 QP Association Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
“It was definitely a very interesting & helpful course.”, John Mekkattu, Manager Quality Assurance, Acino Pharma AG, Switzerland
“Experienced presenters with very good subject knowledge.”, Paul Anderson, G R Lane Health Products, UK
“Good overview of different types of agreements, good to see both the GMP and the legal angle”, A. Michiels, Johnson & Johnson, Belgium
“Both, organizers and lecturers were very friendly, open for discussions and extremely constructive. The course was a valuable experience for me.”, Mariya Dimitrova, NKN Law Firm, Bulgaria
Date & Time
Tue, 4 May 2027, 09:00-17:15 h (Registration 08:30-09:00 h) Wed, 5 May 2027, 08:30-14:45 h
Testimonials
