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AsphaNews 5: May 2014

Read about the most recent changes in the fast-paced fields of drug development, regulatory affairs, and PhV.

Read about the most recent changes in the fast-paced fields of drug development, regulatory affairs, and PhV.
April 29, 2014

Bridging the continents: meet Asphalion’s US Agent in May in Europe!

From the 5th to the 16th May, Bruce Thompson, our U.S. Agent, an expert on FDA regulations and procedures, will be in Europe.

If you would like to have a meeting with us, to get initial advice and to evaluate potential new projects, please contact us at info@asphalion.com.
Free of charge MPDviewer for the current XEVMPD/IDMP legislation

Extedo has released their latest product for the XEVMPD compliance: MPDviewer.

This is a free of charge tool, which has been available from the 9th of April.

Asphalion has been involved in the set-up and testing of the tool. We have already approached our xEVMPD customers to get access, but if you want to have more information, please take a look at the following website
Asphalion supports our clients with the new requirements to update the data before the end of the year.
For more information contact xevmpd@asphalion.com 
EMA introduces new fee incentives for SMEs for post-authorisation activities

The European Medicines Agency has introduced new fee incentives to support micro, small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use. The new incentives apply to post-authorisation activities. They include total or partial fee exemptions for the following activities:

  • extension of a marketing authorisation;
  • type-IA, type-IB or type-II variation;
  • renewal of a marketing authorisation;
  • transfer of a marketing authorisation between two SMEs;
  • referral procedure initiated by the marketing-authorisation holder as laid down in Article 30(1) or the first sub-paragraph of Article 31(1) of Directive 2001/83/EC;
  • post-authorisation annual fee.

Micro-sized enterprises will benefit from a 100% fee reduction, while small and medium-sized enterprises will have a 40% reduction of the total applicable fee.

For further details click here

FDA GDUFA Performance Report

FDA published the Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report. Read more
Asphalion attended DIA’s 26th Annual EuroMeeting in Vienna
Over the years, this conference has become a real centre of attention for regulatory professionals and related life science experts. Read more and see photo of the Asphateam at DIA
New team member
Asphalion is proud to inform you that we have added Mrs. Sonia Lopez to our team as Senior Drug Safety Manager.
Sonia López has more than 13 years’ experience in Pharmacovigilance, and has worked for the last 7 years for a multinational company as the Medical Affairs and Pharmacovigilance Coordinator.
She has also acted as Pharmacovigilance Manager and the EU-QPPV (European Qualified Person Responsible for Pharmacovigilance) where she developed and implemented the Pharmacovigilance system and database. She also collaborated as Pharmacovigilance consultant in the elaboration of the Spanish GVP for pharmaceutical Industry.
Since the year 2000, she is in charge of managing and coordinating the Scientific Committee of Pharmacovigilance of the Spanish Association of Industry Pharmacists (AEFI). She frequently acts as a speaker and trainer in international Pharmacovigilance courses, symposiums and congresses.

Sonia studied Pharmacy at the University of Barcelona and holds a Master’s Degree in Pharmacovigilance and Post-Authorisation Studies from the University of Sevilla.

For more information about our Pharmacovigilance services, please contact: T +34 93 238 59 45 – qppv@asphalion.com

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