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).
Eliane Schmid
Moderation/Leiterin Abteilung Kommunikation
Raimund Bruhin
Direktor Swissmedic
Neue Bereichsleiterin Eveline Trachsel
Das Leitungsteam ZL stellt sich vor
Eveline Trachsel, Bereichsleiterin Zulassung und Arzneimittelsicherheit & die Abteilungsleitenden des Bereichs
Ulla Grauschopf
Leiterin der Abteilung Quality Assessment
Presentation in english
Isabelle Zaugg
Einheitsleiterin Tierarzneimittel
Anna Janitsary
Clinical Assessor, Abteilung Clinical Assessment
Sandra Zaugg
Leiterin der Abteilung Regulatory Assessment
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
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»
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
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.
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»
If you have any questions, please contact our event team: events@swissmedic.ch