SME workshop for micro, small and medium-sized enterprises: Focus on quality for medicines containing chemical entities

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TitleSME workshop for micro, small and medium-sized enterprises: Focus on quality for medicines containing chemical entities
Date04/04/2014 - 04/04/2014
LocationEuropean Medicines Agency, London, UK
SummaryWorkshops for micro, small and medium-sized enterprises (SME) take place at the European Medicines Agency (EMA) annually, and have been organised by the SME Office since 2007. This year we have initiated a workshop with a focus on quality aspects for chemical entities. Topics to be covered include building quality documentation early during development, scientific advice on quality aspects, considerations for veterinary medicines and innovations and emerging topics in pharmaceutical developments. The workshop is open to companies that have been assigned SME status by the EMA and to representatives of stakeholder organisations.

All documents

Name Language First published Last updated
Programme - SME workshop: Focus on quality for medicines containing chemical entities (English only) 15/04/2014  
Presentation - Medicines and Healthcare products Regulatory Agency (MHRA): Overview of applications for Marketing Authorisations – recent experience in assessment of quality (Keith Pugh) (English only) 15/04/2014  
Presentation - Norwegian Medicines Agency: Quality aspects in IMP developments (Tone Agasøster) (English only) 15/04/2014  
Presentation - Good-manufacturing-practice (GMP) issues for start-ups, quality in the supply chain and role of the qualified person (QP) (Patrick Costello) (English only) 15/04/2014  
Presentation - Active substances from starting materials to Active Substance Master Files (ASMFs) (Ruben Pita) (English only) 15/04/2014  
Presentation - European Directorate for the Quality of Medicines and Healthcare (EDQM): The European Pharmacopoeia and certificates of suitability (CEP) (Andrew McMath) (English only) 15/04/2014  
Presentation - Medicines Evaluation Board in the Netherlands: ICH Q3D elemental impurities and ICH M7 mutagenic impurities recent considerations (Diana van Riet-Nales) (English only) 15/04/2014  
Presentation - State Institute for Drug Control (SÚKL): Highlights from recent scientific advice and protocol assistance on quality issues (Blanka Hirschlerová) (English only) 15/04/2014  
Presentation - Irish Medicines Board: Considerations for veterinary scientific advice and marketing authorisations (Mary O’Grady) (English only) 15/04/2014  
Presentation - New active substance categorisation and orphan similarity (Piotr Kozarewicz) (English only) 15/04/2014  
Presentation - Quality aspects of nano-based medicines (Dolores de la Ossa) (English only) 15/04/2014  
Presentation - Medicines Evaluation Board in the Netherlands: Paediatric formulations (Diana van Riet-Nales) (English only) 15/04/2014  
Presentation - Electronic submission of information on medicinal products in accordance to Article 57(2) requirements: Maintenance submission (Ilaria Del Seppia) (English only) 15/04/2014  

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