|
|
|
|
| Participation fee, meals and application |
TO APPLICATION
The participation fee, which includes certificate of completion, coffee and lunch is SEK 2900 before October 22 and SEK 3600 after that date.
All prices given excluding VAT |
| Project Administator |
|
|
Representatives from Health Authorities, Industry and Veterinary Organizations with an interest in the regulation, distribution and availability of veterinary medicines. |
|
Good working examples from both regulators and industry on how to facilitate smooth implementation and maintenance of multilingual veterinary medicine packs will be shared. The symposium will also give a look into a promising future of simplified and pragmatic regulatory approaches to increase availability of veterinary medicines in smaller markets. In addition, time will be devoted for discussions with peers and counterparts on the topics. |
|
| 09.00 |
Registration and coffee |
| 09.30 |
Welcome and Introduction, Rikard Pellas, LIF |
|
- The Nordic VMP market in perspective |
|
- Purpose of the day |
| 09.35 |
Initiatives to increase availability |
|
- Short introduction to European harmonization of nationally SPCs, Alenoosh Abedi, LV |
|
- Authority Initiative II: Work Sharing - Periodic Safety Update Reports and Variations, Alenoosh Abedi and Peter Ekström, LV |
|
- Authority Initiative III: Minor Use Minor Species/Limited Markets. Relevance for the Nordic market, Tita-Maria Muhonen, FIMEA |
|
- Industry Initiative: The 1-1-1 Concept, Rick Clayton, IFAH-Europe |
|
- Temporary authorization and special license Norway, Tonje Höy, NoMA |
| 12.00 |
Lunch |
| 13.00 |
Implementation of updated packaging material - what does it take?, Christer Olsson, Merial |
| 13.30 |
Multi-lingual packs increase availability |
|
- Trade names: Regulations, procedures and experiences, Ylva Satrell, LV |
|
- How to achieve a common trade name, Christer Olsson, Merial |
| 14.30 |
Coffe |
| 14.50 |
- Nordic Labeling: Industry Perspective and Experiences, Britta Rosenqvist, Boehringer Ingelheim |
|
- Nordic Labeling: Regulatory Advice and Experience, Heidi Mustalammi, FIMEA |
|
- Joint labeling assessment: Example from the Baltic states, Marina Stenlander, BMS |
| 16.00 |
Plenary discussions: Regulatory solutions to ensure/increase availability of VMPs in the Nordic Market? Moderator: Jan Ström, LIF |
| 16.45 |
End |
|
|
|
|
|
| |
|
|
|
|
| Time and Location |
The seminar is held on November 22nd, 2012 at the newly opened Clarion Arlanda conferens center, located at he Arlanda Airport (Stockholm). The seminar starts at 9.30 and ends at 16.45.
|
| Application, confirmation etc |
You will receive a confirmation of your registration within a week, acceptance is on a space-available basis. Cancellations can be made at no charge up until 30 days before the start of the seminar. After this our cancellation policy applies, which can be found in the confirmation document and on our home page. Cancellations should be addressed in writing. |
|