European QP Association (EQPA), KisselPharmaConsulting
Dr. Tillmann Lindenblatt
Fisher Clinical Services
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
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.
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.
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.
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/
Programme
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
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