Dr Ina Bach, Dr Bach, form. RHI
Dr Karin Hofstetter, Thermo Fisher Scienific
Dr Felix Kesselring, Bratschi AG Rechtsanwälte
Dr Ulrich Kissel, European QP Association
Dr Carsten Meininghaus, DSM
Jette Petersen, Roche
- 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.
Under the Agreement of 21 June 1999 between the Swiss Confederation and the European Community (Mutual Recognition Agreement, MRA), Switzerland obliged to comply with the EUGMP regulation. This means that the GMP requirements of Directive 2001/83 / EC (in particular Article 46. to 52 for the QP) also apply in Switzerland.
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.
On 1 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.
Responsible Persons/RPs for batch certification and release and Executives and Managers who want to get an overview on the duties and responsibilities of the RP.
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
- Internal delimitation of responsibilities
- Contract RPs
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
Workshop: Certification and Batch Release: to certify or not, that’s the question!
Decision making based on real examples
The Supply Chain
- Requirements in Switzerland and the EU
- Responsibilities of the RP
- Questions, challenges and solutions
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
The Responsible Person’s daily Work: what the RP need to know about:
- Communication and collaboration with the authorities
- Risk Management
- Management Review
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
- Named Patient Import
- Principles of liability
- When will the RP be liable?
- Potential sanctions
- Examples from the real life, case law
Workshop: Quality Control and Laboratory: what the RP needs to know
- OOS, OOE und OOT
- Fault analysis