Swissmedic GMP-Training for Inspectors 2026


5 – 6 May 2026, Montreux, Switzerland

Topic

Inspecting PQS Maturity and the Use of Artificial Intelligence in Pharmaceutical Quality Systems


Experts from industry and government agencies will share their specialist knowledge in the form of presentations and highlight current developments. In three Workshops with case studies, participants will have the opportunity to apply their newly acquired knowledge and exchange professional experiences and best practices.

General Information

  • Venue: Hotel Eden Palace au Lac, Montreux

  • Dates: 5 to 6 May 2026 (check the agenda for the beginning and end of the event)

  • Registration fee: There will be no registration fee. Lunches and coffee breaks during the training are part of the event and will be provided by Swissmedic.

  • Costs for travel and accommodation are on each participants own charge.

Important Information

There has been a strong increase in interest in the Swissmedic GMP-Training for Inspectors over the last few years. Several countries have often been unable to take part in the event due to the limited number of participants. For this reason, it is necessary to register promptly, bearing in mind the following rules:

  • A maximum of 2 persons per inspectorate and country can participate in the GMP-Training.

  • For larger countries with several inspectorates, we only accept 1 person per inspectorate.

  • We reserve the right to put registrations on a waiting list in order to allow as many different countries as possible to participate.


We ask for your understanding for these rules.

Agenda

09:00
Registration & Welcome Coffee
09:30
Welcome address
09:40
Introduction of the topic

Barbara Herzog
Swissmedic

09:45
The revision of ICH Q9

A framework for inspecting PQS Effectiveness and its role in ICH Q12 implementation

Kevin O’Donnell
Market Compliance Manager
HPRA Health Products Regulatory Authority, Ireland (remote)

10:30
ICH Q12, Knowledge Management and PQS

As well as history and evolution of these concepts

Ingrid Markovic
Head of Global RA CMC Policy
Novartis Pharmaceuticals Corporation, USA


11:00
Coffee Break
11:30
Continuation: ICH Q12, Knowledge Management and PQS

As well as history and evolution of these concepts

Ingrid Markovic
Head of Global RA CMC Policy
Novartis Pharmaceuticals Corporation, USA

12:00
Use of AI tools in the context of PQS (industry point of view)

Industry point of view

Gert Thurau
Lead Technology Innovation Manufacturing in CMC Reg Policy
F. Hoffmann-La Roche, Switzerland

13:00
Group Photo
13:15
Lunch Break


14:30
How to inspect AI tools in the context of PQS

tbd

15:10
How to inspect OOS

(see also Guidance for industry: Investigation OOS Test Results for Pharmaceutical Production)

Jay Jariwala
Founder and President
Pharmasure LLC

15:50
Coffee Break
16:20
How to inspect OOT, OOX

Deviations and Management Review

Anna-Maria Kurzreiter
Inspector/Senior Expert
AGES Austrian Agency for Health and Food Safety

17:00
tbd

tbd

17:30
End of the official part of day 1
18:30
Get together

Meeting point at the Hotel du Grand Lac Excelsior

All participants are invited by Swissmedic


Address
Rue de Bon-Port 27, Montreux

Download the agenda as a pdf file

Venue

The GMP-Training for Inspectors 2026 will be held in Montreux, Switzerland.

Montreux is located in French-speaking Switzerland on the shores of Lake Geneva and is known for its mild microclimate, magnificent Belle Époque architecture, and the world-famous Montreux Jazz Festival in July. Surrounded by mountains, the city offers a charming lakeside promenade with flowers, Mediterranean trees, and numerous sculptures.


Our venue, the Hotel Eden Palace au Lac, is centrally located in the heart of Montreux, right on the shores of Lake Geneva. Its excellent location, combined with professional infrastructure and warm hospitality, makes the hotel the ideal place for the GMP-Training 2026.


Address

Hotel Eden Palace au Lac
Rue du Théâtre 11
1820 Montreux
www.edenpalace.ch
meeting@edenpalace.ch
Link Google Maps

Registration

If you wish to register for the GMP-Training for Inspectors 2026, please fill in the registration form. Deadline for registration: 27 April 2026, or as soon as the event is fully booked.

Please note:

  • A maximum of 2 persons per inspectorate and country can participate in the GMP-Training.

  • For larger countries with several inspectorates, we only accept 1 person per inspectorate.

  • We reserve the right to put registrations on a waiting list in order to allow as many different countries as possible to participate.

Accommodation

Montreux is a well known destination all over the world. Hotel accommodation tends to be expensive and the month of May is very popular. For this reason, we have pre-booked rooms in various hotels for the participants.

Booking process

  • All participants are responsible for making their own bookings directly with the desired hotel.

  • Costs for accommodation are at participants own charge.

  • Costs for reserved rooms are subject to the cancellation policy of the respective hotel.

Hotel Eden Palace au Lac (venue)

Hotel Villa Toscane

Hotel Helvétie

Travel Information


Traveling by air

The closest airport to Montreux is Geneva International Airport (GVA). From there, you can easily reach Montreux by train in approximately 75 minutes. Depending on the connection, you will have to change trains.

Travel via Zurich International Airport (ZRH) is also possible. However, the onward train journey is significantly longer, taking about 2 hours and 50 minutes. Depending on the connection, a change of trains may also be necessary.

Link to the Swiss Railway System SBB


Traveling by train

Regular train connections from Bern, Zurich, Lausanne and Geneva take you to Montreux and guarantee access to all international train connections.



How to get to the venue

The Hotel Eden Palace au Lac is approx. 900 metres or a 10-minute walk from Montreux train station. Use the Google Maps route planner for the quickest way. You can choose if you want to take the walk along the lake, for a first impression of beautiful Montreux, of if you wish to follow the main street, the Avenue des Alpes.

Google Maps Hotel Eden Palace au Lac

Evening Programme

The Dinner on the first evening of the GMP-Training (Tuesday 5 May 2026) is almost a tradition in itself. We warmly invite you to make use of the opportunity to make contacts and engage in interesting conversations outside of the seminar room in a relaxed atmosphere. Swissmedic invites all participants to dinner at the Restaurant of the Hotel du Grand Lac Excelsior.

The Hotel du Grand Lac Excelsior is the sister hotel of our conference venue and is located just 850 metres away along Montreux’s picturesque lakeside promenade. Take the opportunity to enjoy a walk along this world-famous promenade in the direction of Château de Chillon.

  • Meeting point: Tuesday 5 May 2026, 18h30 at the Hotel du Grand Lac Excelsior for the Apéro

  • Dinner at approx. 19h30

  • The events ends at approx. 22h00


Address

Hotel du Grand Lac Excelsior

Rue de Bon-Port 27, Montreux
Link to Google Maps for direction

Contact

If you have any questions, please contact the following persons:


Programme co-ordination and content

Barbara Suzanne Herzog
Inspector
Phone + 41 58 414 07 45
barbara.herzog@swissmedic.ch


Organisation & Administration

Nicole Lüthi
Communication Department
Phone +41 58 414 01 99
nicole.luethi@swissmedic.ch