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Certification of suitability (CEP) / Procedure of certification (general) | News | 05 August 2016 | Strasbourg, France
The last monthly activity report for the Certification of Substances Division (DCEP) is now available for July 2016.
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Certification of suitability (CEP) | News | 04 August 2016 | Strasbourg, France
A document has been prepared to provide guidance on the implementation of ICH Q3D on elemental impurities in the context of Certificates of Suitability (CEP).
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Certification of suitability (CEP) | News | 27 July 2016 | Strasbourg, France
The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 03 July 2016 | Strasbourg, France
The EDQM is preparing its next international conference on its Certification Procedure, which will take place in 2017 (final date and European venue to be confirmed in the coming weeks).
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Certification of suitability (CEP) | News | 10 June 2016 | Strasbourg, France
A document has been prepared to provide guidance on the approach taken by EDQM when carrier oils are used with antioxidant in omega 3 type substances.
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EDQM / All activities | News | 24 May 2016 | Strasbourg, France
The EDQM has just published its 2015 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year’s events, achievements, and thanks all involved for their dedication, expertise and support.
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Certification of suitability (CEP) | News | 24 May 2016 | Strasbourg, France
The workshop on the IGDRP initiative, held on 13 May 2016 at the EDQM premises in Strasbourg, brought together 80 regulators, industry representatives and other stakeholders from 29 different countries (including Australia, Brazil, Canada, China, India, Japan, Republic of Korea, Mexico, South Africa and Taiwan).
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Certification of suitability (CEP) / Procedure of certification (general) | News | 04 May 2016 | Strasbourg, France
The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ».
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Products and Services | News | 03 May 2016 | Strasbourg, France
The EDQM will be attending CPhI China in Shanghai from 21-23 June 2016. Come and meet us on Stand E1A19 and learn about the 9th Edition of the European Pharmacopoeia!
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Certification of suitability (CEP) / Procedure of certification (general) | News | 20 April 2016 | Strasbourg, France
The EDQM document PA/PH/CEP (16) 20 explains the impact on CEPs of the revision of titles of existing monographs to implement the Ph. Eur policy for hydrates included in the Ph. Eur. style guide of 2014.
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Certification of suitability (CEP) | News | 29 March 2016 | Strasbourg, France
The EDQM has revised the document “Use of CESP to submit electronic documents to EDQM”. The document has been adapted to be in line with CESP 2.0.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 14 March 2016 | Strasbourg, France
After public consultation, the EDQM has established its roadmap for the submission of CEP applications in electronic format for the next 4 years. This roadmap represents a major change to current practices.
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EDQM / All activities | News | 25 February 2016 | Strasbourg, France
Following a technical issue with the RSS feeds, we are pleased to announce that they are now all operational.
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Certification of suitability (CEP) | News | 03 February 2016 | Strasbourg, France
Within the framework of the 3rd meeting of the International Generic Drug Regulators Programme (IGDRP) in Strasbourg, the EDQM is pleased to organise a one-day workshop on the IGDRP initiative on Friday, 13 May 2016, when industry representatives and other stakeholders will have the opportunity to interact directly with regulators from around the world.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 01 February 2016 | Strasbourg, France
A review of the pricing policy for the activities associated with the procedure for Certificates of suitability to the monographs ...
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