Presentations

CATS Consultants are regularly asked to speak at international conferences.

Regulatory Affairs

2019

  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2019
  • Two-day course: European Union Regulatory Issues – New Product Development, CfPIE, London, United Kingdom, October 2019
  • Typical EU Module 1 Documents, CRED: Critically Evaluating Dossiers. TOPRA, London, United Kingdom, September 2019
  • Brexit: The latest updates, Session Chair, RAPS Regulatory Conference Europe 2019, Brussels, Belgium, May 2019
  • EMA’s PRIority MEdicines Scheme (PRIME): How to Make it More Successful, Session Chair and Speaker, RAPS Regulatory Conference Europe 2019, Brussels, Belgium, May 2019
  • Maintenance of Orphan Drug Designation, Optimising Regulatory Strategies for Orphan Drugs, TOPRA, London, United Kingdom, April 2019

2018

  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2018
  • Two-day course: Filing Variations in the European Union, CfPIE, Berlin, Germany, November 2018
  • Two-day course: European Union Regulatory Issues – New Product Development, CfPIE, Berlin, Germany, November 2018
  • The EU Clinical Trial Regulation: Preparing for Implementation, Session Chair, The Regulatory Convergence, RAPS, Vancouver, Canada, October 2018
  • Two-day course: Filing Variations in the European Union, CfPIE, Berlin, Germany, January/February 2018

2017

  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2017
  • The New Clinical Trials Regulation and Regulatory Affairs Aspects of Medicinal Product Development in the EU, GlobalCompliancePanel, Zurich, Switzerland, June 2017

2016

  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2016
  • Two-day course: European Union Regulatory Issues – New Product Development, CfPIE, Berlin, Germany, October 2016
  • Breakthrough Therapy Designation, Session Chair and Speaker, The Regulatory Convergence, RAPS, San Jose, USA, September 2016
  • The New Clinical Trial Regulation – Focus on IB and IMPD, The Regulatory Convergence, RAPS, San Jose, USA, September 2016

2015

  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2015
  • Two-day course: EU Labelling Requirements, Pharmaceutical Training International, Riga, Latvia, October 2015
  • Two-day course: Filing Variations in the European Union, CfPIE, Berlin, Germany, October 2015
  • Three-day course: EU and US Requirements for Pharmaceutical Labelling & Package Leaflets, Pharmaceutical Training International, London, United Kingdom, June 2015
  • One and a half day course: Regulatory Training Module 3, Luxembourg, Luxembourg, March 2015

2014

  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2014
  • Regulatory Affairs Update 2014, Reinbek, Germany, November 2014
  • Two-day course: Master Regulatory Aspects of your New Medicinal Product Development, EBCG, Basel, Switzerland, October 2014
  • The Voluntary Harmonisation Procedure, The Regulatory Convergence, RAPS, Austin, USA, September 2014
  • Two-day course: Filing Variations in the European Union, CfPIE, Berlin, Germany, May 2014
  • Two-day course: European Union Regulatory Issues – New Product Development, CfPIE, Berlin, Germany, May 2014

2013

  • Two-day course: Filing Variations in the European Union, CfPIE, Berlin, Germany, December 2013
  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2013
  • Two-day course: EU Regulations on Type I and Type II Variations, Academia Life Sciences Center, Istanbul, Turkey, February 2013

2012

  • Two-day course: The European Regulatory Framework for Drugs and Biological Products, Bioforum, Ramat Gan, Israel, December 2012
  • Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2012

2010

  • Regulatory Requirements for Clinical Trials, Regulatory Strategy for a New Active Substance: Global Clinical Development, TOPRA, Brussels, Belgium, October 2010

2008

  • Introduction to the EU Clinical Trial Directive 2001/20/EC, Clinical Trials Summer School, Informa Life Sciences, Cambridge, United Kingdom, September 2008
  • 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
  • European Regulatory Affairs Summer School, Conference Chairman and Speaker, Informa Life Sciences, Cambridge, United Kingdom, July 2008
  • Examining the regulatory perspective on adaptive clinical trials, Adaptive Designs for Clinical Development, Informa Life Sciences, London, United Kingdom, May 2008

2007

  • European Regulatory Affairs Summer School, Conference Chairman and Speaker, Informa Life Sciences, Oxford, United Kingdom, July 2007

2006

  • The FDA process for Scientific Advice, Scientific Advice 2006, IIR Conferences, London, United Kingdom, March 2006

2005

  • Regulatory Requirements in the EU and the US for Similar Biological Medicinal Products, Arbeitskreis Regulatorische Toxikologie, Martinsried, Germany, November 2005
  • Overview of New EU Legislation, RAPS 2005 Annual Conference, RAPS, Baltimore, USA, October 2005
  • The Clinical Trials Directive, RAPS 2005 Annual Conference, RAPS, Baltimore, USA, October 2005
  • Post-Marketing. Principles & Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
  • Overview of Clinical Trials. Principles & Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
  • Marketing Authorization Process. Principles & Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
  • Manufacturing Requirements. Principles & Practices of EU Regulatory Affairs, RAPS, Berlin, Germany, May 2005
  • 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
  • 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
  • Two-day course: Clinical Trials Directive, Pharmaceutical Training International, London, United Kingdom, April 2005
  • Type IA and Type IB Variations, Variations 2005, IIR Conferences, London, United Kingdom, March 2005
  • One day pre-conference workshop: Understanding Regulatory Affairs for generics, 4th Annual Global Generic Strategy Summit, IIR Conferences, Barcelona, Spain, March 2005
  • Two-day course: Regulatory Affairs for Generics, Pharmaceutical Training International, London, United Kingdom, January 2005
  • 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

  • One day post-conference workshop: The Revised Directive Implementation Texts, The Clinical Trials Directive, IIR Conferences, London, United Kingdom, December 2004
  • Two-day course: Regulatory Affairs for Central & Eastern Europe, Pharmaceutical Training International, London, United Kingdom, November 2004
  • SmPC Role and Issues, Challenges in Product Information (PI) - Is a Harmonised View Achievable?, Drug Information Association, Scheveningen, The Netherlands, October 2004
  • 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
  • The ICH Process and the CTD Dossier, International Regulatory Affairs Summer School, IBC Life Sciences, Cambridge, United Kingdom, September 2004
  • Clinical trial applications in the EU and US, Clinical Trials Directive, IIR Conferences, London, United Kingdom, June 2004
  • Variations & Life Cycle Maintenance, Conference Chairman and Speaker, IIR Conferences, London, United Kingdom, May 2004

2003

  • Streamlining your regulatory procedures to successfully file product variations globally, Variations 2003, IIR Conferences, Amsterdam, The Netherlands, October 2003

2002

  • Implementing the CTD, Conference Chairman, IIR Conferences, Amsterdam, The Netherlands, December 2002
  • 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
  • e-Regulatory: Submission of electronic data and documents, PASG Spring Meeting, Meriden, United Kingdom, April 2002
  • Considerations for running the Centralised Procedure, Centralised Procedure Training Meeting, AstraZeneca, Wedel, Germany, January 2002

2001

  • The current regulatory requirements for electronic submissions, Preparing for compulsory electronic submissions, Henry Stewart Conferences, London, United Kingdom, November 2001
  • Electronic Dossier Submissions: View from the Inside, BrAPP Annual Symposium, London, United Kingdom, July 2001
  • Electronic Submissions – What is there to know?, e-SOP’s in Clinical Research, Henry Stewart Conferences, London, United Kingdom, June 2001
  • 2000
  • Operation of the Centralised Procedure during 2000 and changes for 2001, BIRA 2000 Annual Review Meeting, London, United Kingdom, December 2000
  • The Centralised Procedure and the role of the EMEA, IFB Regulatory Affairs Course, London, United Kingdom, November 2000
  • Regulatory Perspective, Product Information Management (PIM), EMEA Open Day, London, United Kingdom, September 2000
  • The EMEA: Role, Structure and Financial Operations, Presentation to the Chinese Health Authorities, Reading, United Kingdom, August 2000
  • Navigating the process, BIRA/ESRA meeting “Optimising your use of the centralized procedure”, London, United Kingdom, February 2000