Rephine Balticum will be participating at the Global Pharmaceutical Regulatory Affairs Summit on 24-26 October in Prague.
WHAT WILL YOU HEAR ABOUT?
The conference includes 4 parallel conference tracks on Regulatory Affairs in Emerging Markets, IDMP Compliance, Global eSubmissions and Biosimilars. Dr. Polina Dombure will represent Rephine Balticum with speach on topic “Bridging East and West: GxP Convergence within the CIS”.
You are welcome to attend this event.
Your invitation from Rephine Balticum means you can benefit from an exclusive 25% discount when you register with the VIP code: CQ5267RBA*.
Places are limited, but you can guarantee your place below.
Book online: Click here to book online
Book by email: email@example.com
Book by telephone: +44 (0) 20 7017 7481
Group booking (3+) discounts: +44 (0) 20 7551 9521
* T&Cs Apply
Looking forward to meeting you at the Summit!
Latvian State Agency of Medicines informs that Latvia also currently is undergoing a gradual transition to all submission of regulatory documents in electronic form only – eCTD (electronic Common Technical Document) format.
January 1, 2021, is set up as deadline when all the circulation of documents must be done electronically – only eCTD format
Companies are encouraged to follow the recommendations of the EU Action Plan and provide only eCTD format for documentation:
- from 1 January 2018 for the mutual recognition procedure
- from 1 July 2018 for registrations in the national registration procedure
- from 1 January 2019 in decentralized, mutual recognition and national procedure
In order to help companies adjust to new requirements, we offer assistance in the form of:
- eCTD management software solution eCTDmanager in EAEU and CIS region
- Training on Regulatory Affairs and eSubmissions topics
- Medicines registration services
- Our partner’s EXTEDO GmbH e-solutions for the electronic registration of medicinal products: e-CTD manager installation and training