Speakers
Dr Ina Bach
Dr Bach AG, form. RHI
Ursula Eggenberger Stöckli
Bratschi Wiederkehr & Buob AG, Lawyers
Susanne Jecklin
Novartis
Dr Carsten Meininghaus
Lonza
Dr Bernd Renger
form. Chairman European QP Association
Objectives
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.
Background
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.
Target Group
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.
Programme
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
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
GDP: The Medicinal Product Supply Chain
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
KPIs
Management Review
Liability
Principles of liability
When will the RP be liable?
Potential sanctions
Examples from the real life, case law
Workshop:
Certification and Batch Release: to certify or not, that’s the question!
Decision making based on real examples
Workshop: Quality Control and Laboratory: what the RP needs to know
Responsibilities
OOS, OOE und OOT
Fault analysis
Statistics
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