Sprecher
Ursula Eggenberger Stöckli, Bratschi Wiederkehr & Buob AG Lawyers
Karin Hofstetter, CSL Behring AG
Dr Ulrich Kissel, European QP Association
Dr Tillmann Lindenblatt, Fisher Clinical Services
Dr Carsten Meininghaus, DSM
Zielsetzung
- Learn and discuss the special tasks and responsibilities of the Responsible Person (RP) in Switzerland (Qualified Person/ QP according EU legislation).
- Exchange opinions and convey possible solutions to problems addressed in case studies and workshops.
- Benefit from the speakers’ experience in industry, authority and legal advice.
Hintergrund
The requirements for a Responsible Person (“Fachtechnisch Verantwortliche Person” in the German speaking part) are described in art. 5, art. 10, art. 14 and art. 15 of the Ordinance on Establishment Licences. With its signature, the RP confirms that a batch meets the specifications and has been manufactured in a GMP-compliant system. This system-related statement is considerably more comprehensive than a batch-related confirmation, which aims solely to comply with the specifications. Therefore the duties and responsibilities can be rather extensive.
In January 2019, the revised Therapeutic Products Act (HMG 2) and amendments to the ordinances (Therapeutic Products Ordinance Package IV) came into force - with some interesting alterations.
Zielgruppe
The European Qualified Person Association
The European Qualified Person Association was founded by the members of the Advisory Board of the European Compliance Academy (ECA) in 2006. It is the only association of its kind and serves Qualified Persons as a platform for the exchange of experiences and allows members to discuss the latest developments and challenges.
Meanwhile, the European Qualified Person Association counts more than 2.700 members and has experienced a correspondingly large international recognition. Membership is open to all registered EU QPs but also to RPs from Switzerland and is free of charge.
Learn more: http://www.qp-association.eu/
Programm
EU Regulations and their Implementation in Switzerland
- Directive 2001/83/EG and the Qualified Person
- Mutual Recognition Agreement
- Ordinance on Establishment Licences OEL (AMBV, OAMéd)
Role and Tasks of the Responsible Person
- The role in the company and the organisation chart
- Batch certification and release
- Cross-boarder activities
- Personal duties and responsibilities
- Delegation
- Deputies
- Internal delimitation of responsibilities
- Contract RPs
Time for discussion
Examples: Certification and Batch Release
- To certify or not, that’s the question
- Decision making process
The GMP/GDP Interface
- Consequences of the Therapeutic Products Act and amendments to Ordinances
- Storage and transport
- Import and export: particularities
- Cool and cold chain issues
- Supply chain traceability
What the Responsible Person needs to know about Investigational Medicinal Products (IMPs)
- The new EU Clinical Trial Regulation and the consequences for Switzerland
- IMP supply to the EU
- IMP transfer in Switzerland
- Labelling
- Named Patient Import
Time for discussion
Outsourcing: What the RP should know about assuring Product Quality
- Compliance with the registration
- Compliance with GMP
- Audits and supplier qualification
- Necessary batch documentation
- Product Quality Review (PQR)
- Delimitation of Responsibilities in the supply chain
- Quality (Technical) Agreement
The API Supply Chain
- Requirements in Switzerland and the EU
- Responsibilities of the RP
- Questions, challenges and solutions
The Responsible Person’s daily Work: what the RP need to know about:
- Communication and collaboration with the authorities
- Risk Management
- KPIs
- Management Review
Liability
- Principles of liability
- When will the RP be liable?
- Potential sanctions
- Examples from the real life, case law
- What the RP needs to know
- Responsibilities
- OOS, OOE und OOT
- Fault analysis
- Statistics
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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