An inverted triangle ‘▼’ is the new symbol to identify medicines undergoing additional safety monitoring.
DRA has further strengthened its Pharmaco-chemical Team with the appointment of a new Regulatory Expert.
European Medicines Agency has published a training video to give guidance on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.
We would like to thank everyone who visited our booth at the 2nd Pharmacovigilance Conference in Helsinki.
We welcome everyone to drop by at our booth for a chat and have a closer look at our services.
The year 2013 started in a significant way for us as we became a company with more than 50 employees by getting three new experts in our team.
DRA will be open normally over the Christmas period only closing on the public holidays.
Next year a black symbol must be included in the SPC and PIL for medicinal products that are under additional monitoring, for example those containing a new pharmaceutical ingredient.
Eija Kinos attended the seminar on Scandinavian Marketing Compliance organised by Läkemedelsakademin on 5-6 December in Denmark.
DRA Consulting was represented by Hanna Saari and Anna Rontu during the seminar on e-submissions on 28 November in Sweden.
See you at Veterinary Medicines Seminar