Presentations
CATS Consultants are regularly asked to speak at international conferences.
Regulatory Affairs
2024
EU revision of the Orphan Drugs Legislation, Optimising Regulatory Strategies for Orphan Drugs, TOPRA, live online, November 2024
Maintenance of Orphan Drug Designation, Optimising Regulatory Strategies for Orphan Drugs, TOPRA, live online, November 2024
Regulatory Lifecycle Management in The EU (Filing Variations), Educo Life Siences, live online, November 2024
Understanding EU regulatory affairs, Educo Life Sciences, live online, August - October 2024
2023
EU revision of the Orphan Drugs Legislation, Optimising Regulatory Strategies for Orphan Drugs, TOPRA, Berlin, October 2023
Maintenance of Orphan Drug Designation, Optimising Regulatory Strategies for Orphan Drugs, TOPRA, Berlin, October 2023
2022
The EU Clinical Trial Regulation, RAPS, live online, February 2022
RA Considerations During Clinical Development in the EU, RAPS, live online, February 2022
2021
Anticancer Drug Development: The Regulatory Environment, Oncology Drug Development in Practice, Congress by design, Amsterdam, The Netherlands, November 2021
Maintenance of Orphan Drug Designation, Optimising Regulatory Strategies for Orphan Drugs, TOPRA, live online, March 2021
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