Felix Kesselring
Bratschi Rechtsanwälte
Referent:innen
Dr Carsten Meininghaus
DSM Nutritional Products
Dr Ina Bach
Dr. Bach
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Karin Hofstetter
BioAtrium
Jette Petersen
F. Hoffmann-La Roche
Course in Englisch language
Zielgruppe
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.
Zielsetzung
- 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 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.
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.
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.
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 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.
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.
Programm
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
- 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
INTERACTIVE SESSION
Certification and Batch Release: to certify or not, that’s the question!
Decision making based on real examples
Certification and Batch Release: to certify or not, that’s the question!
Decision making based on real examples
The API 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 needs to know about:
- Communication and collaboration with the authorities
- Risk Management
- KPIs
- 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
- Labelling
- Named Patient Import
Liability
- Principles of liability
- When will the RP be liable?
- Potential sanctions
- Examples from the real life, case law
INTERACTIVE SESSION
Quality Control and Laboratory: what the RP needs to know
Quality Control and Laboratory: what the RP needs to know
- Responsibilities
- OOS, OOE und OOT
- Fault Analysis
- Statistics
Weitere Informationen
Venue
Hotel Ambassador & Spa
Seftigenstrasse 99
3007 Bern
Switzerland
+41 (0)31 370 99 99
ambassador@fhotels.ch
Hotel Ambassador & Spa
Seftigenstrasse 99
3007 Bern
Switzerland
+41 (0)31 370 99 99
ambassador@fhotels.ch
CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive an information form when you have registeredfor the course. Reservation should be made directly with the hotel. Early reservation is recommended.
COURSE IN ENGLISH LANGUAGE
Fees
€ 1.790,- for QP Assocation Members (equates 1.667 CHF, dated July 2025)
€ .1990,- for Non-Members (equates 1.853 CHF, dated July 2025)
Relevant for payment is the price in Euro. The conference fee is payable in advance after receipt of invoice and includes conference documentation (download), lunch on both days and all refreshments.
VAT is reclaimable.
€ .1990,- for Non-Members (equates 1.853 CHF, dated July 2025)
Relevant for payment is the price in Euro. The conference fee is payable in advance after receipt of invoice and includes conference documentation (download), lunch on both days and all refreshments.
VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Teilnahmegebühr
| Regular Fee*: | € 1990,- |
| EU/GMP Inspectorates*: | € 845,- |
| QP Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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