Regulatory Affairs Workshop

The workshop „Regulatory Affairs“ has been since many years an integral part of the Annual Congresses of GA. It provides a platform to address selected topics in the field of regulatory affairs related to herbal medicines. Moreover, the workshop serves as a platform for establishing networks, as it brings together regulators, industry representatives, and scientists.

The workshop will be chaired by Prof. Dr. Knöss, BfArM (Federal Institute for Drugs and Medical Devices), Bonn. The workshop „Regulatory Affairs“ is an integral part of the annual meetings of GA. It is providing a platform to focus on selected topics in the field of regulatory affairs related to herbal medicines. Moreover, the workshop offers options to establish networks and bring together regulators, industry representatives and scientists.

The objective is to stimulate an extensive dialogue between science and regulation. At this year´s workshop participants will get insight into the regulatory framework for herbal medicines in Switzerland, where complementary therapies have a particular status and a high level of acceptance. The Swiss population clearly voted in favor of herbal and complementary medicines. A specific regulatory framework has been established including provisions for reimbursement. The presentations will cover different perspectives such as the view of the national regulatory agency Swissmedic, challenges faced by a pharmaceutical company and contributions from scientists to the establishments of regulatory standards. Participants shall learn and understand the different perspectives and actively join the discussion about the following questions:

What can regulators learn from science? What can scientists contribute to regulation? How can research support regulation?

Program Workshop Regulatory Affairs, 13.30 – 17.00

Regulation of complementary and herbal medicines in Switzerland – a particular environment and platform for an extended dialogue

Sunday, 3rd September 2017
13.30 Welcome and introduction
Science and regulatory affairs – dialogue and cooperation
Werner Knöss (BfArM, Germany)
13.45 – 14.20 Regulator´s perspective (25—30 minutes and discussion)
Regulation of herbal and complementary medicines in Switzerland
Dr. Martin Ziak (Swissmedic, Switzerland)
14.20 – 14.55 Industry´s perspective (25—30 minutes and discussion)
Particular challenges for a pharmaceutical company
Dr. Christiane Halbsguth, Dr. Catherine Zahner, Zeller AG, Switzerland
14.55 – 15.25 Coffee-break
15.25 – 16.00 Science and regulation (25—30 minutes and discussion)Contributions to regulation from scientific institutions
Dr. Evelyn Wolfram (ZHAW, Wädenswil, Switzerland)
16.00 – 17.00 Discussion with speakers and participants
a) Science and regulation – milestones, incentives and ideas towards an improved and beneficial exchange
b) Expectations to future workshops on regulatory affairs