Aika ja paikka

To 22.09.2022 kello 09:30-16:00
Kesto: 1 päivä
Sokos Hotel Presidentti, Eteläinen Rautatiekatu 4, 00100, Helsinki

Hinta

495.00€
(+ alv)

THIS IS A HYBRID EVENT.

Mention in the additional information field whether you prefer to participate live event or live webinar.

Are there multiple attendees for this event?

Ask for a group offer sales@laaketietokeskus.fi


 
Sokos Hotel Presidentti Helsinki 00100

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 - 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 Center 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 in Helsinki.

 

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 sales@laaketietokeskus.fi

 

Please read the changes and cancellations policy before registering to the event on the website at: Instructions for participants.