This content applies to human and veterinary medicines.
As well as day-to-day regulatory assistance, the SME office engages with SMEs and stakeholders at conferences, congresses and roundtable events. SME outreach activities include info days, newsletters and targeted communications to increase the regulatory knowledge base of SMEs.
Quarterly newsletters highlight news, documents and activities in the EU regulatory environment of relevance to SMEs and their stakeholders.
Info days and training
The SME office hosts educational meetings each year which are available for attendance in person or remotely. Video recordings, presentations and related information for each event are available under:
- SME info day on the new clinical trial regulation (20/03/2017)
- Focus on non-clinical aspects (03/10/2016)
- Statistical perspectives in regulatory clinical development programmes (05/02/2016)
- Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies (16/04/2015)
- Focus on quality for medicines containing chemical entities (04/04/2014)
- Veterinary regulatory support for SMEs (07/11/2013)
- EMA regulatory support pre- and post-authorisation (26/04/2013)
- Focus on pharmacovigilance (19/04/2012)
- Focus on scientific and regulatory advice (26/05/2011)
- Regulatory considerations in initiating clinical trials (28/05/2010)
- Paediatric medicines (22/10/2009)
- Focus on non-clinical aspects (01/02/2009)
- Focus on quality (02/02/2008)
- Navigating the regulatory maze (01/02/2007)
SME reports and surveys
The SME office reports on the SME initiative and EMA's interaction with pharmaceutical industry associations representing SMEs.
- Report on the 10th anniversary of the SME initiative (May 2016)
- Survey on the implementation of the SME regulation (May 2016)
- 10th anniversary roundtable meeting (December 2015)
- Survey on the implementation of the SME regulation (2011)
- Report on the 6th anniversary of the SME initiative (December 2012)
Further sources of SME support
- Overview of current initiatives at European Union level to assist micro, small and medium-sized enterprises with financing (December 2014)
- Summary of European Union (EU) support to micro, small and medium-sized enterprises in health research: Horizon 2020 – The EU research and innovation programme for 2014-2020
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