At the end of April we had an intensive two days of pharmacovigilance training with focus on GVP guidelines. We hope that all participants gained new knowledge and got an insight of how system changes will affect the day-to-day pharmacovigilance operations within the pharmaceutical companies by learning from practical examples, which are based on real life situations.
Thanks to all who participated and especially to our brilliant trainer José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) who has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and Electronic transmissions in Project Manager role.
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
eSubmissions 2 day practical training held on 6 – 7 April was another successful event for those who are facing electronic submissions of data on their daily work.
We had the honor to present Ralf-Peter Berg – Director of Extedo’s Education team who is responsible for all training courses. Implementation of time-saving strategies for streamlining eSubmissions and many more topics were discussed as well as practical skills were acquired by having eCTD demo version in a practical hands on session in a computer classroom.
Thanks again to our amazing trainer and also to all of our participants!
If you are also interested in taking part in one of our upcoming events stay tuned by subscribing to our newsletter or follow Course Calendar on our website.
Last week has been very intensive by having almost fully booked and successful event: Good Manufacturing Course. Many important topics were discussed between our attendees – pharmaceutical industry experts and our distinguished trainers Marian San and Eduard Cayón
Thanks again to our amazing trainers and also to all of our participants!
If you are also interested in taking part in one of our upcoming events stay tuned by subscribing to our newsletter or follow Course Calendar on our website. For further information or initial consultation do not hesitate to contact us directly. Looking forward to seeing you!
Transatlantic agreement will help to make better use of inspection capacity and reduce duplication
Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.
Each year, national competent authorities from the EU and the US Food and Drug AdministrationExternal link icon (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s inspections in their own territories. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be limited to exceptional circumstances.
The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union.
Read full article HERE
“Our network of regional partners is a vital component of the EXTEDO solution. Leading consultancy firms such as Rephine Balticum provide our mutual clients with regional regulatory expertize and enable us to offer local product services and support,” said Christian Bohrmann, VP Marketing & Alliances at EXTEDO.
The EXTEDOsuite is the only Regulatory Information Management System to include planning & tracking, product registration, submission publishing and lifecycle management, pharmacovigilance management and drug safety. Through Effortless Compliance™, it ensures a healthy relationship between industry and the authorities.
EXTEDO is proud to include the Baltic and CIS region in our existing portfolio of industry leading partnerships.
Read full article here.
On June 16, 2016, the President of Ukraine signed the Amendments to the Medicines Act, which are intended to simplify the procedure of state registration of medicines coming from countries with strong established regulatory requirements, institutions, and procedures. The changes will become effective starting from their official publication day and responsible government agencies must still adjust certain bylaws to implement them.
Extended list of medicines subject to the simplified procedure
Now all medicines (drugs) registered by a competent authority of the USA (i.e., FDA), Switzerland, Canada, Australia, Japan, and the EU are now subject to the simplified registration procedure. Whereas the previous version of the Medicines Act allowed such simplified procedures only for medicines that treat tuberculosis, HIV/AIDS, viral hepatitis, oncological, and rare (orphan) illnesses.
Read Full article HERE.
“Ongoing revision: Regulation proposals of the European Commission
In 2012, the Commission adopted a package of measures on innovation in health.
The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.
The revisions affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.”
Read European Commission’s full article HERE.
This means changes in classification for Medical devices, requirements for registration and distribution. We would kindly invite you to register for our open class on 9- 10 November 2017, where all those topics are going to be looked through and discussed.