European QP Association (EQPA), KisselPharmaConsulting
Dr Carsten Meininghaus
DSM Nutritional Products
Dr Ina Bach
Dr. Bach
Dr Karin Hofstetter
BioAtrium
Jette Petersen
F. Hoffmann-La Roche
Felix Kesselring
Bratschi Rechtsanwälte
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 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.
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.
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Testimonials
Seminar Programme as PDF