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CATS Consultants are regularly asked to speak at
international conferences.
Regulatory Affairs
Please find below an overview of the topics we have
covered in the past.
2008
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Introduction to the EU
Clinical Trial Directive 2001/20/EC, Clinical Trials Summer School, Informa
Life Sciences, Cambridge, United Kingdom, September 2008
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Outlining
the key aspects of
clinical trial guidelines and directives and introducing the regulators,
Clinical Trials Summer School, Informa Life Sciences, Cambridge, United
Kingdom, September 2008
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European Regulatory
Affairs Summer School, Conference Chairman and Speaker, Informa Life
Sciences, Cambridge, United Kingdom, July 2008
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Examining the regulatory perspective on adaptive
clinical trials. Adaptive Designs for Clinical Development, Informa Life Sciences,
London, United Kingdom, May
2008
2007
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European Regulatory Affairs Summer School. Conference
Chairman and Speaker, Informa Life Sciences, Oxford, United Kingdom, July
2007
2006
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The FDA
process for Scientific Advice. Scientific Advice 2006, IIR Conferences, London, United Kingdom,
March 2006
2005
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Regulatory Requirements in the EU and
the US for Similar Biological Medicinal Products, Arbeitskreis Regulatorische
Toxikologie, Martinsried, Germany, November 2005
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Overview of new EU legislation, RAPS
2005 Annual Conference, RAPS, Baltimore, USA, October 2005
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The Clinical Trials Directive, RAPS
2005 Annual Conference, RAPS, Baltimore, USA, October 2005
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Post-Marketing. Principles & Practices
of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
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Overview of Clinical Trials.
Principles & Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
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Marketing Authorization Process.
Principles & Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
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Manufacturing Requirements. Principles
& Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
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Guideline on the requirements to the
chemical and pharmaceutical quality documentation concerning investigational
medicinal products in clinical trials CHMP/QWP/185401/2004. Clinical Trials
Directive, IIR Conferences, Paris, France, April 2005
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One day pre-conference workshop: A
review of the most recent updates of implementation texts and national
guidelines. Clinical Trials Directive, IIR Conferences, Paris, France, April
2005
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Two day course: Clinical Trials
Directive, Pharmaceutical Training International, London, United Kingdom, April
2005
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Type IA and Type IB Variations,
Variations 2005, IIR Conferences, London, United Kingdom, March 2005
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One day pre-conference workshop:
Understanding Regulatory Affairs for generics, 4th Annual Global
Generic Strategy Summit, IIR Conferences, Barcelona, Spain, March 2005
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Two day course: Regulatory Affairs for Generics,
Pharmaceutical Training International, London, United Kingdom, January 2005
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Two day registration training: EU legislation review with an
overview of upcoming changes and Type I & Type II variations, PTI and PTMS,
Istanbul, Turkey, January 2005
2004
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One day post-conference workshop: The Revised Directive Implementation
Texts, The Clinical Trials Directive, IIR Conferences,
London, United Kingdom, December 2004
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Two day course: Regulatory Affairs for Central &
Eastern Europe, Pharmaceutical Training International, London,
United Kingdom, November 2004
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SmPC Role and Issues, Challenges in
Product Information (PI) - Is a Harmonised View Achievable?, Drug Information
Association, Scheveningen, The Netherlands, October 2004
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The evolving regulatory framework in
an EU of 25 members, The Centralised and Mutual
Recognition Procedures in an Enlarged EU, IIR Conferences, London, United
Kingdom, September
2004
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The ICH Process and the CTD Dossier,
International Regulatory Affairs Summer School, IBC Life Sciences, Cambridge,
United Kingdom, September 2004
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Clinical trial applications in the EU
and US, Clinical Trials Directive, IIR Conferences, London, United Kingdom, June
2004
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Variations & Life Cycle Maintenance,
Conference Chairman and Speaker, IIR Conferences, London, United Kingdom, May
2004
2003
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Streamlining your regulatory
procedures to successfully file product variations globally, Variations 2003,
Amsterdam, The Netherlands, October 2003
2002
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Implementing the CTD, Conference
Chairman, IIR Conferences, Amsterdam, The Netherlands, December 2002
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Filing eCTD Centralised applications –
how will these be processed by the EMEA, Rapporteur, Co-rapporteur and the CPMP
members?, The Electronic Common Technical Document and Electronic Submissions,
IBC Life Sciences Conferences, London, United Kingdom, September 2002
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e-Regulatory: Submission of electronic
data and documents, PASG Spring Meeting, Meriden, United Kingdom, April 2002
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Considerations for running the
Centralised Procedure, Centralised Procedure Training Meeting, AstraZeneca,
Wedel, Germany, January 2002
2001
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The current regulatory requirements
for electronic submissions, Preparing for compulsory electronic submissions,
Henry Stewart Conferences, London, United Kingdom, November 2001
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Electronic Dossier Submissions: View
from the Inside, BrAPP Annual Symposium, London, United Kingdom, July 2001
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Electronic Submissions – What is there
to know?, e-SOP’s in Clinical Research, Henry Stewart Conferences, London,
United Kingdom, June 2001
2000
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Operation of the Centralised Procedure
during 2000 and changes for 2001, BIRA 2000 Annual Review Meeting, London,
United Kingdom, December 2000
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The Centralised Procedure and the role
of the EMEA, IFB Regulatory Affairs Course, London, United Kingdom, November
2000
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Regulatory Perspective, Product Information Management
(PIM), EMEA Open Day, London, United Kingdom, September 2000
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The EMEA: Role, Structure and
Financial Operations, Presentation to the Chinese Health Authorities, Reading,
United Kingdom, August 2000
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Navigating the process, BIRA/ESRA meeting “Optimising your
use of the centralised procedure”, London, United Kingdom, February 2000
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CATS
Consultants GmbH