CV of Ruth Paul

EDUCATION

University of Bath, B.Sc., Biochemistry, Honours Degree, 1989.

SUMMARY OF EXPERIENCE

More than seventeen years regulatory experience in the pharmaceutical industry and for Contract Research Organisations.

EXPERIENCE

Freelance Regulatory Consultant, October 2003

I have recently set up my own regulatory consultancy specialising in European product registration. I offer a regulatory consulting service covering all aspects of regulatory affairs for pharmaceutical and biological/ biotechnological products, including dossier preparation and the preparation of clinical trial applications. Ongoing projects are as follows-

• Providing full regulatory support (including MAA and clinical trial applications) for a European company that has 2 products registered in the USA and is now going into Europe.
• Advising a small company on how to register its first product in Europe using the Mutual Recognition procedure.
  
  

Regulatory Manager, SIMBEC RESEARCH Ltd, Merthyr Tydfil, Feb 1999 to October 2003

I was responsible for setting up the Regulatory Affairs department at Simbec and bringing in much of the work. I prepared the quotes for all new regulatory work and ensured all projects were completed on time, within budget and met the client’s expectations. Key projects included-

• Submitting 3 new products via the Centralised system
• Providing regulatory support (including CTX preparation) for the development of a humanized Monoclonal Antibody.
• Taking a new product through the Mutual Recognition system.
• Writing a manual on how to prepare a CTD (Common Technical Document) for a new product (on behalf of a client).
• Providing regulatory support for the development of a new herbal product
• Preparation of a CTX for a new vaccine
• Preparation of a CTX for a New Active Substance
• Gaining 2 PhEur Certificates of Suitability for pharmaceutical ingredients.

Regulatory Consultant, PAREXEL International Corporation, Uxbridge, UK, 1996- Feb 99

Responsibilities included the compilation of European Marketing Authorisation Applications (MAA’s) for centralised, mutual recognition and national applications; the review of draft dossiers and the provision of technical and strategic advice; the design and presentation of training seminars on European regulatory topics and the preparation of expert reports.

European Regulatory Advisor, Alpha Therapeutic Corporation, Thetford, Norfolk, UK, 1991-1996.

Responsibilities included the preparation of MAA’s for both Alpha and Green Cross products; liaison with European Health Authorities; the provision of regulatory advice to the US and Japanese parent companies; the co-ordination of Alpha’s responses on new draft CPMP guidelines and PhEur monographs and the provision of regulatory support for licensed products. As the project leader for specific regulatory projects, I was also responsible for regulatory input into the development program for products for the European market.

Registration Executive, The Wellcome Foundation, Ltd., Beckenham, Kent, UK, 1989-1991.

Responsibilities included developing the regulatory strategy and providing regulatory support for specific countries including France, Austria, Switzerland, Portugal, Greece and Israel as well as providing input on behalf of these countries into each stage of product development.

PROFESSIONAL AFFILIATIONS

Member, The Organisation for Professionals in Regulatory Affairs.

SPEAKER AT MEETINGS

• June 1998; IBC meeting; spoke on European Regulatory requirements for new products
• June 1999; IBC meeting; spoke on European Regulatory requirements for biological and biotechnological products
• June 2000; DIA meeting; spoke on regulatory requirements for active ingredients
• June 2002; DIA meeting; spoke on the role of the EU national agencies in European Regulatory Affairs Today.
• Oct 2002: DrugDev meeting; chaired a meeting on the new Clinical Trials Directive.

PUBLICATIONS

• Ruth Paul; "Case study: EU submission"; Drug Discovery and Development; Spring 2000.
• Ruth Paul; "Centralised and Mutual Recognition Procedures"; GOR vol 2 no 1; Spring 2000.
• Ruth Paul; "The Role of the EU National Agencies in European Regulatory Affairs Today"; EPC Autumn 2002.