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: registrations@informa-ls.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, 2020 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 mutual recognition procedure
  • from 1 July 2018  for registrations in national registration procedure
  • from 1 January 2019 in decentralized, mutual recognition and national procedure

FULL INFORMATION

 

In order to help companies adjust to new requirements, we offer assistance in the form of:

  • Trainings 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

More information: info@rephinebalticum.com