The QP in Switzerland - Role, Accountability and Liability of the Responsible Person
Course in english language!

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.

Hintergrund

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.

Important Information!

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.