Wednesday, 03 June 2020
09.30 – 09.40 Introduction
09.40 – 10.30
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)
10.30 – 10.50 Coffee Break
10.50 – 12.00
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
12.00 – 12.15
Time for discussion
12.15 – 13.20 Lunch break
13.20 – 15.20
Examples: Certification and Batch Release
- To certify or not, that’s the question
- Decision making process
15.20 – 15.40 Coffee break
15.40 – 16.20
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
16.20 – 17.20
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
17.20 – 17.30
Time for discussion
Thursday, 04 June 2020
09.00 – 09.50
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
09.50 – 10.40
The API Supply Chain
- Requirements in Switzerland and the EU
- Responsibilities of the RP
- Questions, challenges and solutions
10.40 – 11.00 Coffee break
11.00 – 12.00
The Responsible Person’s daily Work: what the RP need to know about:
- Communication and collaboration with the authorities
- Risk Management
- KPIs
- Management Review
12.00 – 12.45
Liability
- Principles of liability
- When will the RP be liable?
- Potential sanctions
- Examples from the real life, case law
13.00 – 14.00 Lunch break
14.00 – 15.30
Examples: Quality Control and Laboratory
- What the RP needs to know
- Responsibilities
- OOS, OOE und OOT
- Fault analysis
- Statistics