Medfiles organizing a training event on borderline products in Tallinn


Oy Medfiles Ltd, a Nordic–Baltic CRO, is inviting you to a training event organized in Tallinn:

Crossing the borderlines – could my product be a medical device or food with a claim?

Recently more and more “drug like” products have entered on the market via other product categories. There are eye drops available as medical devices, food supplements with diverse health claims and cosmetic products indicated for treatment of hoarse throat. The regulatory status for the products on the borderline between medicinal products and food products, cosmetic products and medical devices can be difficult to determine and the field seems to become more complex all the time. Conflicting law decisions and continuous updating of regulations make it even more confusing.
In this event you will learn the basics how to determine the status of a borderline product – the appropriate product class for your new invention or product idea. You will also gain a deeper understanding on two product groups and related legislations – medical devices and foods with claims. For more detailed information, please see the program below.
After the event you are more aware of what makes the difference between particular product groups and what are the regulatory aspects that you need to take into account when working with medical devices or products under the food law in EU.

Wednesday 8th April 2015 at 12.00 – 16.00

Technopolis Ülemiste AS, Lõõtsa 8a, 11415 Tallinn

12.00  Welcome and introduction of the day
Malle Jaagola (M. Pharm.), Regulatory Affairs Manager / Baltic countries, Medfiles OÜ

12.15  Borderline products – What makes the difference between medicines, medical devices, food supplements, cosmetics and biocides?
Laura Salminen (M.Sc), Regulatory Affairs Manager, Medical Devices, Medfiles Ltd

13.15  Health effects of foods and food supplements – what can be claimed under the EU food law?
Essi Sarkkinen (Ph.D , Docent at University of Eastern Finland), Senior Regulatory Affairs Expert, Food & Nutrition, Medfiles Ltd

14.15  Coffee break

14.45 Medical devices – requirements and practices of CE marking process
Laura Salminen (M.Sc), Regulatory Affairs Manager, Medical Devices, Medfiles Ltd

15.45  Closing of the day
Malle Jaagola (M. Pharm.), Regulatory Affairs Manager / Baltic countries, Medfiles OÜ

All presentations are held in English.

Participation fee
50 euros per participant. (Sales not including VAT – Reverse charge, intangible service. Oy Medfiles Ltd VAT number: FI10475691).
The fee includes course documentation in electronic form submitted to the participants after the seminar as well as mid-session refreshments. For payment details please see Registration.

Please fill in a registration form not later than 25.3.2015.

Pay the participation fee not later than 25.3.2015:
Bank: Nordea Bank Finland Plc, Helsinki
Recipient: Oy Medfiles Ltd
IBAN: FI0823291800140368
Please make sure your name is mentioned in the reference field of the payment. If several participation fees are paid simultaneously the names of all participants have to be mentioned in the reference field.

Additional information
If you have any questions please send email to info(a) or call Malle Jaagola tel. + 372 5660 0090

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