Programme Swissmedic Workshop „Update on GCP/GVP

Programme
Swissmedic Workshop „Update on GCP/GVP Inspections“
Monday, 10 November 2014, 13h30 – 17h00
Inselspital Bern, Hörsaal 7, Auditorium Langhans, Pathologisches Institut H 128, Entry 43 A
Time
Theme
13:00 – 13:30
Registration and Coffee
13:30 – 13:40
Opening and introduction
13:40 – 14:20
The GCP inspection process: Presentation and
discussions
14:20 – 15:00
Finding/Gradings/Statistics: Presentation and
discussions
15:00 – 15:30
Coffee Break
15:30 – 16:10
GVP Inspections: Presentation and discussions
16:10 – 16:40
Advanced Therapy Inspections
16:40 – 17:00
Discussions and Closing remarks
Speaker
Dr. Françoise Jaquet
Head of Division Clinical Trials, Swissmedic
Dr. Simone Ferbitz-Scheurer
GCP/GVP Inspector, Division Clinical Trials,
Swissmedic
Dr. Thomas Richter
GCP/GVP Inspector, Division Clinical Trials,
Swissmedic
Dr. Julia Abegglen
GVP/GCP Inspector, Division Clinical Trials,
Swissmedic
Dr. Thomas Schwartz
Clinical Reviewer, Division Market
Surveillance, Swissmedic
PD Dr. Andreas Marti
GCP Inspector, Coordinator Gene Therapy,
Division Inspectorates, Swissmedic
Dr. Mirela Barbu
Head of GCP and GVP Inspectorate, Division
Clinical Trials, Swissmedic
All presentations will be held in English. Print outs of all presentations will be provided. After the Workshop, the
presentations will be available on the Swissmedic Website for download.
The Certificates of Attendance will be distributed at the end of the Workshop.
Continuous education credits given by the medical associations:
Swiss Society of Pharmaceutical Medicine (SGPM/ASMP):
Swiss Association of Pharmaceutical Professionals (SwAPP):
Swiss Society of Clinical Pharmacology and Toxicology (SSCPT)
applied
applied
3 points
Swissmedic | Swiss Agency for Therapeutic Products | Hallerstrasse 7 | CH-3000 Bern 9 | www.swissmedic.ch | Tel. +41 31 322 02 11 | Fax +41 31 322 02 12

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