Dr Ina Bach, Dr Bach AG, form. RHI
Ursula Eggenberger Stöckli, Bratschi Wiederkehr & Buob AG, Lawyers
Susanne Jecklin, CSL Behring AG
Dr Ulrich Kissel, European QP Association
Dr Tillmann Lindenblatt, Fisher Clinical Services
Dr Carsten Meininghaus, Lonza
- 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.
When it comes to the manufacturing of medicinal products, applicable GMP regulations and the role of the Responsible Person, the Ordinance on Establishment Licences (Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd) refers to the relevant EU law.
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 EU-GMP 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.
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.
The presentations of the course will be available for download and your print-out one week before and after the conference.
Note: there will be no print-outs available during the course.
EU Regulations and their Implementation in Switzerland
Role and Tasks of the Responsible Person
- Directive 2001/83/EG and the Qualified Person
- Mutual Recognition Agreement
- Ordinance on Establishment Licences OEL (AMBV, OAMéd)
Outsourcing: What the RP should know about assuring Product Quality
- 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
The API Supply Chain
- 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
GDP: The Medicinal Product 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:
- 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)
- Communication and collaboration with the authorities
- Risk Management
- Management Review
- The new EU Clinical Trial Regulation and the consequences for Switzerland
- IMP supply to the EU
- IMP transfer in Switzerland
- Named Patient Import
Workshop:Certification and Batch Release: to certify or not, that’s the question!
- Principles of liability
- When will the RP be liable?
- Potential sanctions
- Examples from the real life, case law
Decision making based on real examples
Workshop: Quality Control and Laboratory: what the RP needs to know
- OOS, OOE und OOT
- Fault analysis