Date and place

Thu 03.09.2020 at 09:00-16:30
Duration: 1 day
REMOTE, 00000, Helsinki

Hinta

425.00€
(+ VAT)

The Nordic Regulatory Affairs Seminar will bring the Nordic authorities and pharmaceutical industry operators together to discuss the hottest topics remotely! 


Participate in topical discussions and network with colleagues and industry partners. Participate safely in the live webinar or watch a recording of it later. We would like to warmly welcome you to the virtual 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.

Programme



(Time Zone UTC+3, Finland)


9:00 Virtual Networking


9:30 Welcome and introduction

Moderator: Laura Merisaari, Regulatory Affairs Manager, Bayer Oy


FUTURE OUTLOOK


9:35 Marketing Authorisations in the EU - European Pharmaceutical Strategy and Implications in Practice
Sini Eskola, Director of Regulatory Affairs, EFPIA


10:10 Charting New Waters: Taking a CAR-T to Sea
Geneviève Le Visage, Head of RA EU Policy and Liaison, Novartis 

 

10:45  Break 1/3 - Virtual Networking (20 min)

 

11:05 Artificial Intelligence in Regulatory Affairs
Nikolai Constantin Brun, Director of Division, Head of Medical. CMO. Division for Medical Evaluation and Biostatistics, Danish Medicine Agency

 

11:45 EMA's Current Topics: the European medicines agencies network strategy to 2025, current and future initiatives regarding stakeholder engagement, shortages and ePI
Juan García Burgos, Head of Public and Stakeholders Engagement Department, European Medicines Agency

 

12:15 Break 2/3 - Virtual Networking (60 min)


13:15 UPDATE FROM THE NORDIC AUTHORITIES

Moderator: Pasi Virta, Responsible Pharmacist, Pfizer

 
● Current topics on marketing authorisations
● Current topics on availability of medicines and solutions to shortages
● COVID-19 impacts and what we could learn for the future  

 

13:20 Danish Medicine Agency
Nikolai Constantin Brun, Director of Division, Head of Medical. CMO. Division for Medical Evaluation and Biostatistics, Danish Medicine Agency

 

13:40 The Finnish Medicines Agency Fimea
Päivi Jutila, Coordinator for Marketing Authorisations, CMDh Member 

 

14:00 Swedish Medical Products Agency
Stefan Berggren, Deputy Director div. for Supervision - Head of Swedish Competence Center for Pharma in the Environment 
 

14:20 The Norwegian Medicines Agency
Dag Jordbru, Strategic Director, Safe Use   


14:40 Break 3/3 - Virtual Networking (20 min)


15:00 Notifications of Medicine Shortages in Vnr Service
Riikka Leppänen, Information Pharmacist, Pharmaceutical Information Centre


15:15 DISCUSSION, QUESTIONS AND ANSWERS
Moderator: Pasi Virta, Responsible Pharmacist, Pfizer Finland
Participants: Nordic Authorities & other speakers & the audience


Topics for discussion include:


● EMA’s new requirements and reasons 
● Medicine shortages and electronic patient information leaflets
● Other solutions for managing shortages
● Good practices in notification procedures


16:15-16:30 Summary and end of the seminar
Moderators: Laura Merisaari, Regulatory Affairs Manager, Bayer Oy, and
Pasi Virta, Responsible Pharmacist, Pfizer Finland

 

About the event


To ensure the safety, Nordic Regulatory Affairs Seminar 2020 will be organised remotely. 
 

The virtual event will be held from 9.00 am to 4.15 pm Finnish time. Networking starts at 9.00 am. The programme starts at 9.30 am.


You will be able to ask the speakers questions via the chat. You will also receive a recording of the webinar after the seminar, which will be available for one month.
 

We also offer a virtual networking platform for you and your professional interests!


Please note that event is subject to changes due to the COVID-19 situation.

Price


Webinar price EUR 425 + VAT. The price includes electronic training materials


Is there a group of you coming? Ask for a group discount from your event contact!

Further information and registration


Register to the event 31th August at the latest via the link to registration. 


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

The streaming of this seminar is funded by Nordplus Horizontal Programme.