Register
Saturday, September 04, 2010
Past Events
Regulatory Strategy:

The New Medicines Legislation: Meeting Chair and Presenter; How to Run a Successful MRP or DCP – Applying Current Experiences to the New Procedures.
Management Forum, London 12 December 2005.

Clarification and Examination of the Centralised Procedure.
Implementing New Medicines Legislation, IIR Conferences. London, UK, 25 January 2006.

The New Medicines Legislation – Post Implementation Report.
Informa Life Sciences Annual European Regulatory Affairs Summer School. Cambridge, UK, 18 July 2006 and Oxford, UK 25 July 2007

The New Routes to Gaining Regulatory Approval In Europe, One Year On. Meeting Chair and Presenter: (i) The New Routes to Regulatory Approval - Status of Implementation of the Review (ii) Examination of the Centralised Procedure.
Management Forum. London, UK, 28 November 2006.

eCTD:

Maxim Pharmaceuticals Ceplene: Filing the first Centralised MA eCTD to the ICH V3.0 Specification. IBC’s 3rd European Conference on Filing eCTDs and Managing eSubmissions, 21 June 2004, London, UK.

Submitting an eCTD: A Case Study Presentation.
MHRA Conference on Impact of the CTD, 16 September 2004, London.

Case Study - Outsourced Approach to Submitting eCTDs; Practical Experiences.
Filing eCTDs and Managing eSubmissions, IBC Conferences, 20 June 2005, Amsterdam, The Netherlands.

Drug Development:

Overview of Current EU Regulatory Requirements and Environment for Novel Drug Delivery Devices. The Regulatory Affairs Professionals Society Global Awareness: EU Drugs and Biologics Conference, 15-16 January 2002, Alexandria, Virginia USA.

Regulatory Considerations in the Clinical Development of COPD Drugs. Smi 2nd Annual Conference on Chronic Obstructive Pulmonary Disease. 10 March 2004, London, UK.

Regulatory Affairs for Biotech.
Pharmaceutical Training International, 19 May 2004, London, UK. Course Tutor.

Regulatory Considerations in the Clinical Development of COPD Drugs.
Annual Conference on COPD, Management Forum, 12 November 2004, London.

Effective Switching from Prescription to Over-the-Counter Status: Role in Product Life-Cycle Development.
Session Chair. DIA Annual Meeting, 28 June 2005, Washington, DC, USA

Paediatric Regulation:

The Paediatric Regulation – How to Optimise Your Clinical Development Process (joint presentation with Peter Bogaert, Partner and Head, Life Sciences, Covington and Burling LLP). EU PHARMA LAW AND REGULATION - How to Maximise Your IP Portfolio and Protect Your Market Share, C5 Conferences, London 21 June 2007.

Exploring the Implications of the 2007 Paediatrics Regulation. Seventh Annual Pharma Law Conference, ViB Events Limited, 10 October 2007, London.

The Paediatric Investigation Plan: Strategic and Operational Considerations.
EU Peadiatric Legislation Opportunities, Challenges and Routes to Successful Compliance, Management Forum, London, 30 November 2007.

The Paediatric Development of Off-patent Drugs.
EU Peadiatric Legislation Opportunities, Challenges and Routes to Successful Compliance, Management Forum, London, 30 November 2007.

Scientific Advice:

Successfully Working with EU Regulators to Obtain Maximum Benefit from Scientific Advice.
IIR One Day WorkShop 16 September 2003, London, UK. Course Tutor.

Managing a Scientific Advice Procedure for the Best Outcome.
IIR Scientific Advice 2005 24 May 2005, London, UK.

Routes to Obtaining Scientific Advice in Europe and How to get the Best out of Each.
Management Forum, London, UK, 19 November 2003, 27 January 2005, 7 February 2006 and 20 February 2007.

Regulatory Scientific Advice in Europe. Informa Life Sciences Annual European Regulatory Affairs Summer School, Oxford, UK. 24 July 2007

Patient information:

Patient Information, Product Labelling and the Safe Use of Medicines.
EU Focus. 3rd Annual Pharmaceutical Packaging and Labelling Forum. Vision in Business. 27 October 2004, London.

The Patient Information Leaflet and the Safe Use of Medicines.
Management Forum in Association with MHRA and the National Patient Safety Agency. London UK, 1 July 2003, 12 July 2004, 11 July 2005, 4 July 2006.

Complying with harmonized patient information leaflet and labelling of pharmaceuticals across the EU: the Mutual Recognition and Decentralised procedures.
IIR Pharmaceutical Labelling and Packaging 2006 Summit. London, UK, 18 September 2006.


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