Dr. Carsten Coors
Vetter Development Services Austria
Referierende
Dr Rainer Gnibl
GMP Inspector
Dr. Monika Hupfauf
Attorney-at Law, Austria
Every participant will get contract examples
Highlights:
- GMP Requirements
- Legal Knowledge
- Practical Perspective
Highlights:
- GMP Requirements
- Legal Knowledge
- Practical Perspective
Zielgruppe
- Personnel involved in the preparation and implementation of contracts
- Decision makers and responsible persons
- Contract giver and contract acceptor
Zielsetzung
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)
Mr Wolfgang Schmitt, Concept Heidelberg
(on behalf of ECA)
Programm
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.
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.
Weitere Informationen
Venue
DoubleTree by Hilton Berlin Ku´Damm
Los-Angeles-Platz 1
10789 Berlin, Germany
+49 30 2127 714
info@doubletreeberlinkudamm.com
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.
Get-Together
On 4 May, you are cordially invited to a Get-Together. 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.
On 4 May, you are cordially invited to a Get-Together. 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.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Testimonials:
- “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
Datum & Uhrzeiten
Tue, 4 May 2027, 09:00-17:15 h
(Registration 08:30-09:00 h)
Wed, 5 May 2027, 08:30-14:45 h
(Registration 08:30-09:00 h)
Wed, 5 May 2027, 08:30-14:45 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
| European QP Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Teilnehmerstimmen - das sagen andere über unsere Seminare:
