The Nordic Regulatory Affairs Seminar will bring the Nordic authorities and pharmaceutical industry operators together to discuss the hottest topics! Speakers are leading experts in the field from Nordic countries. The program is created together with industry experts, and it is based on previous event’s participant feedback and needs assessment for the NRA Seminar 2022.
Participate in topical discussions, meet with your colleagues and network with industry partners. You can participate in the live webinar in Helsinki or online, or watch a recording of it later (1 month). We would like to warmly welcome you to the event!
Who should attend?
Professionals who have an interest in regulatory affairs, quality and supplier chain with an EU/Nordic focus will benefit from attending the seminar. We welcome participants from pharmaceutical companies, pharmaceutical industry associations, national competent authorities, contract research organizations and consultants.
Program
9.00 Registration and coffee, networking
9.30 Welcome and introduction
Ouli Uimonen, CEO, Pharmaceutical Information Centre Ltd
Milla Kajanne, Learning Manager, Pharmaceutical Information Centre Ltd
Moderator Kirsi Nikkola, Talent Development Lead, Team Coordinator, Regulatory Expert,
DRA Consulting Oy
9.40 Current and future topics in EFPIA
Sini Eskola, Director Regulatory Strategy, EFPIA
- Status update: Marketing Authorisations in the EU - European Pharmaceutical Strategy and Implications in Practice
- Sustainability and Environment in Focus
- What does the Regulatory Future look like – Potential Impacts of the ongoing EC revision of the pharmaceutical legislation
10.20 New Veterinary Regulation
- Experiences, Learnings and Best Practices
- Pain Points
Authority viewpoint
Paula Kajaste, Coordinator for Marketing Authorisations, Fimea
Pharma Company viewpoint
Ville Pöyri, Nordic Corporate Account Manager, MSD
10.55 Radiopharmaceuticals from regulatory affairs perspective
Elina Krannila, Senior Regulatory Affairs Expert, Medfiles Ltd
11.15 Lunch break and networking 2/3
12.25 UPDATE FROM THE NORDIC AUTHORITIES
Moderator Kirsi Nikkola, Talent Development Lead, Team Coordinator, Regulatory Expert, DRA Consulting Oy
Introduction to the Nordic collaboration now
Presentation themes are:
- Ongoing Nordic Collaboration projects
- Key projects and activities in each country
- In which EU level / EMA projects your country is actively participating?
12.30 Danish Medicine Agency
12.45 Finnish Medicines Agency Fimea
13.00 Swedish Medical Products Agency
13.15 Norwegian Medicines Agency
13.30 Icelandic Medicines Agency
13.45 DISCUSSION ON THE NORDIC TOPICS, QUESTIONS AND ANSWERS
Participants: Nordic Authorities, Seminar Participants
Moderator Kirsi Nikkola
14.10 Coffee break
14.35 DADI – How to use Digital Application Dataset Integration in Regulatory Processes
Roadmap, steps, effects
Speaker to be confirmed soon
15.05 New RA Topic
Speaker to be confirmed soon
15.35 Current topics from VNR Administration in the Nordic context
Essi Kariaho, Director of Pharmaceutical information, Pharmaceutical Information Centre Ltd
15.55 Summary and end of the Seminar
Moderator Kirsi Nikkola, Talent Development Lead, Team Coordinator, Regulatory Expert,
DRA Consulting Oy
Milla Kajanne, Learning Manager, Pharmaceutical Information Centre Ltd
16.00 End of the Seminar
About the training
The training takes place on 22nd of September 2022 from 9.30 am to 4.00 pm Finnish time.
Come to the event in Helsinki or participate via the live webinar. Please note that there is only room for a restricted amount of participants on the spot, so book your seat soon. Please inform us in the Registration form / Additional information, whether you will attend via webinar or in Helsinki.
Participants will be able to ask the speakers questions via the chat.
Everybody will also receive a recording of the webinar after the seminar, and it will be available for one month.
Please note that event is subject to changes due to the COVID-19 situation. The webinar and the recording will be available in any case.
Price and registration
Early Bird price of the webinar is 495 € (+VAT) until 18.8.2022. Normal price for the event is 595 € (+VAT). The price includes electronic training materials and catering.
You can register using the registration form on this web page.
Is there a group of you coming? Ask for a group discount from your event contact or koulutus@laaketietokeskus.fi.
Please read the changes and cancellations policy before registering to the event on the website at: Instructions for participants.