Workshop on veterinary regulatory support for micro, small and medium-sized enterprises (SMEs)

• Date:
  Thursday, 7 November 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Workshops for micro, small and medium-sized enterprises (SMEs) take place at the EMA annually, and have been organised by the SME Office since 2007. The workshops had joint human-veterinary topics until 2012.In 2013 we have initiated a veterinary specific workshop which aims to provide practical information for SMEs working in the veterinary medicines field. Topics to be covered include MUMS designation, scientific advice, the centralised application for marketing authorisation and inspections.The workshop is open to companies that have been assigned SME status by the EMA and to representatives of stakeholder organisations. Other participants will be welcome space permitting.

Documents

Agenda - Programme - Workshop on veterinary regulatory support for micro, small and medium-sized enterprises (SMEs)

Reference Number: EMA/339258/2013

Presentation - Update from SME Office (Constantinos Ziogas)

Presentation - MUMS Designation and latest develompments (Karen Quigley)

Presentation - EMA Scientific Advice SME (Rory Breathnach)

Presentation - Regulatory issues in the run-up to dossier submission Inspections (Claudio Facchini)

Presentation - MRLs for active substances and excipients (Isaura Duarte)

Presentation - Marketing Authorisation Issues for SMEs (Anna-Maria Brady)

Presentation - Issues for Immunologicals for SME applicants (Jean-Claude Rouby)

Presentation - Eligibility issues and meeting opportunities (Fia Westerholm)

Presentation - Key elements of the review of veterinary legislation (David Mackay)

Multimedia