TOPRA in Sweden
Sixth networking and regulatory update meeting
Tuesday 16 April 2013, 19:00
Medical Products Agency, Uppsala
The evening will be an ideal opportunity to hear the latest about TOPRA as well as catch up with news on pharmaceuticals and medical devices. It will also be the perfect opportunity to network with regulatory colleagues from Sweden in a relaxed and sociable setting.
Välkommen/Welcome - Margareth Jorvid, TOPRA
Regulatory news for pharmaceuticals - Christer Backman, MPA
Regulatory news for medical devices - Helena Dzojic, MPA
MPA’s support to Life Science - Susanne Baltzer, MPA
TOPRA Update - Margareth Jorvid, TOPRA (education, information, networking
A light buffet will be served following the presentations. The event will finish at 21.00.
Clinical Trials event in Stockholm - 23 October 2012
The evening begins with light refreshments
Vera Franzén, Consultant, Vera Franzén Consulting
Isabella Sanderfelt, Registration Manager, Pfizer
News from the MPA:
- MPA reflections on Commission proposals on new Regulation for Clinical Trials
- Compassionate Use Program
Gunilla Andrew-Nielsen, Head of Clinical Trials and Licences, MPA
Live or let Die? Is there a future for clinical trials in Sweden? Industry's views on the proposal.
Johan Brun, Medical Director, Head of Medical Access, Pfizer
A CRO industry in change - what changes drive development and what are the consequences?
Ola Jeppsson, Vice president, IRW Consulting
Regulatory networking and information meeting in Malmö, 12 September 2012
TOPRA in Sweden organised a regulatory network and information meeting in Malmö last month.
This meeting was open to regulatory professionals in both Sweden and Denmark, where colleagues could hear the latest information on current topics.
Welcome, meet colleagues, sandwiches served, coffee / tea, fruit and juice
Welcome to Medeon
Introduction/TOPRA, Margareth Jorvid, LSM group
Regulatory news for pharmaceuticals and the work at the Danish Health and Medicines Authority Steffen Thirstrup, DHMA
Combination products – what pharma RA professionals need to know about devices, and device QA/RA professionals need to know about medicinal products, Margareth Jorvid, LSM group
Break (10 min)
Notified Body role and work – will it change with the new EU device legislation? Sofia Faraasen, BSI
Panel discussion, Time for Q&A with speakers and Ellen Jespersen, Medical Devices, DHMA
Mingle, coffee / tea - meet, ask questions, share experiences
Time: 17.30 to 20.30
Fee: Free for Members, 375 SEK (incl VAT) for Non-members
Location: Medeon, Per Albin Hanssons v 41, Malmö
Join TOPRA and attend this meeting for free, see www.topra.org
TOPRA in Sweden Medical Device Meeting Technology - 17 April 2012
Medical technology - networking and information meeting in Uppsala,
April 17, 2012
TOPRA in Sweden is organizing a regulatory network and information meeting in Uppsala.Meet colleagues and hear latest information on current topics.
18.00-18.30 Welcome, meet colleagues, sandwiches served, coffee / tea, fruit and juice
18.30-18.35 Introduction: Margareth Jorvid, LSM group (5 min)
18.35-19.05 Medical Technology at the MPA: Marie Hansson, MPA (30 min)
19.05-19.35 Notified Body role and work: Sofia Faraasen, BSI (30 min)
break (5 min)
19.40-20.10 Q-Med - a company experiences Sinéad Breen, Q-Med/Galderma (30 min)
20.10-20.40 "My 3 minutes" - 10 delegates will have 3 minutes each to introduce themselves - get to know each other better – pre-registration (see below) (30 min)
20.40-21.00 Mingle, coffee / tea - meet, ask questions, share experiences (20 min)
Time: 18:00 to 21:00
Location: Conference Room at Park Inn Hotel, Storgatan 30, Uppsala
Many thanks for all support. We received positive feedback from both attendees and speakers.
Attached for your convenience are three presentations that were presented during the event.