Regulatory & Beyond 2024


Tuesday, 26 November 2024, Kursaal Bern

The Swissmedic information event "Regulatory & Beyond", previously entitled "Regulatory News", has established itself in recent years as an essential platform for experts in the field of medicinal product authorisation and the regulatory environment in Switzerland. It serves as a central meeting point where businesses, marketing authorisation holders and authorities have the opportunity to learn about and discuss the latest developments, regulatory challenges and strategic innovations. The event encourages participants to share their knowledge and experiences with a view to actively shaping the future of medicinal product regulation in Switzerland.

  • Regulatory complex: Challenges in the regulatory environment

  • Regulatory known: Answers to frequently asked questions and real-life case studies

  • Regulatory new: The latest developments in medicinal product authorisation and what tasks lie ahead

  • Regulatory different: In a separate break-out session in the afternoon, we will cover the challenges in the area of complementary and herbal medicines.

At the Swissmedic market during the lunch break and at the drinks reception afterwards, you will be able to gain insights into our various divisions and groundbreaking projects at various stands:

  • Meet your Regulatory Manager/Regulatory Associate: get to know "your" Regulatory Manager/Regulatory Associate in person

  • Safety of Medicines Division

  • Veterinary Medicines Division

  • Transformation of Swissmedic platforms

  • Real World Evidence (presented by the Clinical Assessment Department

  • Project "Orbis" - a poster session by the Clinical Assessment Department


Administrative information

  • Language: German and French. The speakers will give their presentations in their language. The presentations will be interpreted simultaneously into German and French. Some presentations will be given in English and will not be interpreted (see programme).

  • Event type: This is planned as an in-person event. We will offer the option of following the event via livestream. The break-out session on complementary and herbal medicines will not be streamed (online participation not possible).

  • Participation fees: CHF 500 (for either in-person or online participation)

  • Presentations: The presentations will be available on the Swissmedic website in German, French, English and Italian after the event. A link will be e-mailed to all participants.

  • Certificate of participation: After the event, all participants will receive a link to download their personal certificate of participation.

  • Recordings: The event will NOT be recorded.

  • Registration: Now open; please use the registration form on this page


Note for online participants

  • The online broadcast will be conducted as a webinar (one-way only to the audience). It will not be possible to take part in discussions during the event.

  • You will receive the link for online participation by e-mail a few days before the event.

  • Participants will be able to ask questions via Slido.

  • Swissmedic offers no technical support should external participants have reception issues.

  • Microphones and cameras must remain switched off at all times.

  • We can only issue certificates of participation for registered persons who logged onto the webinar platform with their full name (first name and last name).

Agenda

November 26
08:15
Registrierung und Begrüssungskaffee
09:00
Einleitung & Begrüssung

Eliane Schmid
Moderation/Leiterin Abteilung Kommunikation

09:05
Rückblick, aktuelle und zukünftige Herausforderungen

Raimund Bruhin
Direktor Swissmedic

09:20
Bereich Zulassung und Vigilance Arzneimittel
  • Neue Bereichsleiterin Eveline Trachsel

  • Das Leitungsteam ZL stellt sich vor

Eveline Trachsel, Bereichsleiterin Zulassung und Arzneimittelsicherheit & die Abteilungsleitenden des Bereichs

09:50
Schweizer Umsetzung revidierte EC Variations Guideline – Alter Wein in neuen Schläuchen?

Ulla Grauschopf
Leiterin der Abteilung Quality Assessment

10:10
Kaffeepause
10:40
Avian influenza – an animal and human threat

Presentation in english

Isabelle Zaugg
Einheitsleiterin Tierarzneimittel


Anna Janitsary
Clinical Assessor, Abteilung Clinical Assessment

11:00
Good Regulatory Practice – Empfehlungen für eine effiziente Gesuchabwicklung

Sandra Zaugg
Leiterin der Abteilung Regulatory Assessment

11:20
Internationale Zusammenarbeit

Rückblick/Ausblick Access

Cornelia Bigler
Regulatory Manager, Abteilung Regulatory Assessment


Rückblick/Ausblick Orbis

Eiman Atiek
Regulatory Manager, Abteilung Regulatory Assessment


Rückblick/Ausblick EMA Open

Gabriela Zenhäusern
Wissenschaftliche Mitarbeiterin, stv. Abteilungsleiterin, Abteilung Stakeholder Engagement


Marketing Authorisation for Global Health Products

Lodovico Paganini
Wissenschaftlicher Mitarbeiter, Abteilung Stakeholder Engagement

12:15
Mittagspause mit Stehlunch & Swissmedic Markt

mit Ständen und Poster Session zu folgenden Themen:

  • Meet your Regulatory Manager/Regulatory Associate (Stand)

  • Abteilung Arzneimittelsicherheit (Stand)

  • Abteilung Tierarzneimittel (Stand)

  • Projekt Transformation Swissmedic Plattformen (TSP) (Stand)

  • Real World Evidence (Stand der Abteilung Clinical Assessment)

  • Abteilung Klinische Versuche (Stand)

  • Poster Session der Abteilung Clinical Assessment zum Projekt «Orbis»

  • Poster Session «Nitrosamine Impurities - Testing is key»

13:40
Session "Beyond"

Session "Beyond"

Raum Arena

Simultanübersetzung Deutsch-Französisch


Evidenzbasierte Zulassung der Zukunft/Regulatory Science

Eveline Trachsel
Leiterin Bereich Zulassung & Arzneimittelsicherheit



Innovation Office – Eine erste Bilanz

Philippe Girard
Leiter Bereich Bewilligungen & Überwachung Arzneimittel



Vergütung von Arzneimitteln in der Schweiz

Jörg Indermitte
Bundesamt für Gesundheit BAG



Sex and gender as the gateway to precision medicine

Referat in englisch

Antonella Santuccione Chadha
CEO Pro Bono Women's Brain Project



Swissmedic 4.0 - Digitalisierung konkret

Michael Renaudin
Leiter Abteilung Swissmedic 4.0



Digitalisierungsreise der Swissmedic – Entwicklung Swissmedic Portal

Roger Rüegg
Leiter/Programmverantwortlicher TSP



Schlusswort

Eveline Trachsel

13:40
Session KPA

Breakout Session Komplementär- und Phytoarzneimittel

Raum Szenario 1 & 2

Referate in Deutsch, ohne Simultan-Übersetzung



Begrüssung

Martin Ziak & Bilkis Heneka
Leiter Abteilung KPA / Quality Assessor KPA, Stv. Abteilungsleitung



Pharmazeutische Äquivalenz und Verträglichkeitsbeleg bei einer Literaturdokumentation für Phytoarzneimittel mit «traditioneller Verwendung» und «Well Established use»

Tobias Schlechtinger
Regulatory Manager KPA



EU-Pflanzenmonografien des Committee on Herbal Medicinal Products der EMA (HMPC) und ihre Anwendbarkeit für die Zulassung in der Schweiz

Anne-Isabelle Reich
Regulatory Manager KPA



Best practice für die Zulassung und den Life Cycle von Komplementär- und Phytoarzneimittel

Julie Morciano
Regulatory Manager KPA



Komplementärarzneimittel im Meldeverfahren heute und morgen: Weiterentwicklung vor dem Hintergrund von TSP und IDMP

Conwitha Lapke
Quality Assessor KPA



Regulatorische «Splitter»

N.N.

16:00
Apéro & Swissmedic Markt

Mit Ständen und Poster Session zu folgenden Themen:

  • Meet your Regulatory Manager/Regulatory Associate (stand)

  • Abteilung Arzneimittelsicherheit (Stand)

  • Abteilung Tierarzneimittel (Stand)

  • Projekt Transformation Swissmedic Plattformen (TSP) (Stand)

  • Real World Evidence (Stand der Abteilung Clinical Assessment)

  • Abteilung Klinische Versuche (Stand)

  • Poster Session der Abteilung Clinical Assessment zum Projekt «Orbis»

  • Poster Session «Nitrosamine Impurities - Testing is key»

17:30
Ende der Veranstaltung

Registration

Venue

Kursaal Bern

Kornhausstrasse 3, Bern
3013 Bern

Contact

If you have any questions, please contact our event team: events@swissmedic.ch