18.12.2013

Best Wishes for Christmas and the New Year

DRA will be open normally over the Christmas period only closing on the public holidays.

27.11.2013

Regulatory Intelligence further strengthened at DRA

We have further strengthened our Regulatory team with the welcome addition of Regulatory Expert, Mirjam Linnanen B.Sc. (Pharm.).

01.11.2013

Come see us at ISPOR 16th Annual European Congress on 2-6 November 2013 in Dublin

The congress is a forum for health care researchers, health technology assessors, manufacturers, governments, and patients to debate health care decision-making policies & processes.

21.10.2013

Meet DRA at the CPhI Worldwide 2013 in Frankfurt on 22-24 October

Meet face-to-face with international pharmaceutical companies and remain one step ahead of a constantly changing pharmaceutical market.

02.10.2013

Changes to information reported on CEPs

According to the new guidelines, all sites involved in the manufacture of the active substance must be included in the CEP.

26.09.2013

Further strength for our Regulatory team

DRA is pleased to announce that Svetlana Fedorova B.Sc. (Pharm.) has joined our Regulatory team as Regulatory Expert.

19.09.2013

Risk management plan – what is new?

According to the new Pharmacovigilance Legislation, all new marketing authorisation applications must contain a Risk Management Plan (RMP).

26.08.2013

New team appointments

DRA reinforced its translation team in June with the appointment of Seija Anttila (BA).

15.05.2013

EMA’s list of Black triangle medicines has been published

The European Medicines Agency (EMA) has published the initial list of medicines that are subject to additional monitoring.

25.04.2013

New FDA/EU Approach to Process Validation

Jenni Hannukainen attended the conference “The New FDA/EU Approach to Process Validation” on 23-24 April in Denmark.

18.04.2013

DRA scores high in client satisfaction and quality rating

We regularly survey the status of our clientships and collect feedback to develop our activities.

11.04.2013

DRA to host EuDRAcon network meeting on 11-13 April in Saariselkä

EuDRAcon is a pan-European network of regulatory affairs consultancy companies and its annual meeting begins today at DRA and then continues in Finnish Lapland.

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