Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert ID: 107649 Oklahoma, USA
Expert has over 30 years of experience in the registration of medical devices, ranging from wound dressings to orthopaedic implants and contraceptive devices. He has considerable experience with the European Community (EC) Medical Device Directive, which covers Class I through Class III devices, including devices that contain an active drug substance. as well as with the FDA. ExpertBiggs can advise on the implementation of the Active Implantable Medical Device Directive (AIMDD). He has also worked with many "Notified Bodies," and "Competent Authorities." In addition, he has experience in classification, risk analysis, and regulatory appeals. Also acts as an expert witness. Authorised representative service can be provided.
Over the past several years Expert has dealt with registration and reimbursement issues for in vitro diagnostics. Expertisel with the EC In Vitro Diagnostics Directive 98/79/EC.
Expert has expert knowledge of the UK reimbursement legislation and success in obtaining the UK reimbursement for many appliances, drugs, devices, medicines, reagents, dermatologicals, foods, and drug/device combinations. In particular, ExpertBiggs has successful experience in obtaining reimbursement at public expense for osmotic products, wound care materials, and contraceptives. He can also advise clients on strategies to obtain reimbursement of borderline substances such as foods and cosmetics. Acts s an expert witness with respect to Appeals.
Expert has successfully registered several veterinary drugs in the UK, including vaccines, topical products, and aerosol presentations.
Expert has expert knowledge of herbal medicines and related niche areas within the USA, United Kingdom and the EC.
Due to his excellent background, Expert is highly qualified and experienced to handle drug-device combination products on a pan-European basis.
Over the years, Expert has successfully advised numerous companies regarding their regulatory and marketing strategy within the EC. He can assist with developing strategies to delay or help generic entry in order to optimize profits on a pan-European basis.
Expert has devoted 30 years representing various interests on British Pharmacopoeia working parties, drafting CEN standards, and making representations to European Pharmacopoeia for both pharmaceuticals and devices.
Expert has assisted numerous health care companies in implementing ISO 13485 quality systems with a view to obtain a CE mark.
Expert has experience introducing new products and even acquisition prospects to a wide spectrum of companies, including start-ups and new ventures.
Expert has advised and assisted many U.S. companies entering the EU on developing new dosage forms that will be medically and commercially acceptable within the EU.
Expert employs a team of regulatory specialists who can handle a broad spectrum of issues.
Expert can prepare all stages of FDA and EU marketing authorization applications for EU Member States or via EMEA.
Expert has 30 years experience with EU drug and drug/device registration.
Expert's company can provide stability testing to EU standards for solid and liquid dosage forms with the exception of vaccines, aerosols and ampoules. They can also develop stability indicating methods for most active substances.
Expert has acted as an expert witness in matters relating the legal requirements for drug testing.
Expert has current experience in drafting US, UK and EU patent applications.
Expert can act as an advisor and expert witness on EU Directives relating to drugs, devices, cosmetics and some aspects of compeition law.
Expert can assist clients in drafting mid-level quality management systems and also standard operating procedures to EU/ISO standards.
Expert can advise on the strategies adopted in the UK for healthcare and means of using the system to the advantage of the client particularly with respect to pricing and government reimbursement issues.
Expert has obtained CE marks for many types of medical device including Class III medical devices that contain an active pharmaceutical substance.
Expert can advise on the validation of new process procedures.
Expert will advise on how medical devices can be modified or improved to obtain greater market share.
Expert can find and recommend relevant EU-based test houses for these purposes and advise on approiate test methods.
Expert will act as the reporter to Competent Authorities for the EU vigilance system i.e. authorised representative service and act as the USA representaitve for the FDA.
He can advise on EU medical device reporting requirements.
Expert has current experience in obtaining UK and EU Marketing Authorizations (MAs) for OTC medicines as well as in the USA.
Expert can advise on NICE investigations in the UK and macro changes in the market and development novel cost effectiveness strategies.
Expert can advise on medium- and long-term strategic changes in the UK market and how best to take advantage of those changes.
He has obtained UK reimbursement and CE marks for dozens of wound care products and holds two patents for novel wound irrigation solutions. He has published several papers on wound healing and also the reimbursement of wound healing products in the UK.
Expert operates an EU Authorized Representative Service for non-EU based companies wishing to establish themselves within the EU.
Expert has expert knowledge of obtaining public funding for borderline substances such as foods, nutraceuticals and cosmetics.
Expert is very knowledgeable and can assist in this area. He notes that no medical device or IVD is automatically reimbursed at public expense in the UK even though a CE mark may have been granted. The UK operates a "white list" of branded products that can be prescribed at public expense in the community by doctors and Nurse Prescribers. Unless a medical device/IVD is listed in the UK white list of appliances known as the Drug Tariff, then the demand for the product will be virtually nothing, as patients in the UK will generally not pay privately for medical devices and IVDs.
Expert advised Pfizer to seek a Judicial Review concerning Viagra.He advised Aventis on reimbursement and pricing issues. Expert obtained reimbursement for 3M Micropore tape at premium prices.He obtained Marketing Authorization (i.e., official marketing approval) and reimbursement for calcium alginate. Expert acted as an EU Authorized Representative for many device and cosmetics companies at early stages of EU marketing.
Expert may consult nationally and internationally, and is also local to the following cities: Oklahoma City, Oklahoma - Tulsa, Oklahoma - Norman, Oklahoma - Lawton, Oklahoma - Broken Arrow, Oklahoma - Edmond, Oklahoma
|Year: 2004||Degree: PhD||Subject: Health Economics||Institution: Canterbury Univeristy|
|Year: 1968||Degree: MSc||Subject: Marketing Economics and Statistics||Institution: Manchester University|
|Year: 1967||Degree: BA||Subject: Social Sciences and Statistics||Institution: Nottingham University|
|Years: 1979 to Present||Employer: Undisclosed||Title: Consultant||Department: Registration/Marketing||Responsibilities: handles the registration of drugs, devices and drug device combinations in both Europe and the USA. Company is the only UK consultancy to specialize in reimbursement issues, as far as we
are aware. The undersigned has been a member of three British Pharmacopoeia Working Parties and on various BSI Technical Committees. Now employs a team of regulatory consultants with
clients based all over the world.
|Years: 1972 to 1973||Employer: Sherwood Medical Industries||Title: Product Manager||Department: Syringes, Needles catheters||Responsibilities: Marketing reimbursement of sterile syringes needles and catheters.|
|Years: 1970 to 1973||Employer: 3M and Riker Labs||Title: Product Coordinator||Department: Medical and Dental Products Division/Riker||Responsibilities: He was involved in the marketing of 3M Riker drugs and some medical/dental devices.|
|Years: 1968 to 1970||Employer: BRITISH OXYGEN CRYOGENICS DIVISION||Title: Marketing Assistant||Department:||Responsibilities: Expert provided marketing support for cryogenic gases and containers.|
|Years: 1990 to 2007||Agency: U.K. Department of Health||Role:||Description: Expert has coordinated or advised on ten successful legal actions against the U.K. Department of Health, including the Viagra case. Also involved in legal reviews of drug device issues with the MHRA|
|Years||Country / Region||Summary|
|Years: to Present||Country / Region: USA||Summary: Expert advised many private and public companies on EU regulatory, development and production issues|
|Years: to Present||Country / Region: France||Summary: He advises Les Laboratoires Brothier on registration and reimbursement issues.|
|Years: to Present||Country / Region: Switzerland||Summary: Expert advises several Swiss pharmaceutical companies on EU/UK registration and reimbursement issues.|
|Years: to Present||Country / Region: Italy||Summary: He advises two Italian companies on registration and U.K. pricing/reimbursement issues.|
|Years: to Present||Country / Region: Africa||Summary: Expert advises Xechem International Inc and Natracine Ltd on production, development and regulatory issues in Nigeria and South Africa.|
|Associations / Societies|
|Expert is a Fellow of the Royal Society of Medicine and a member of the Expert Witness Institute|
|Publications and Patents Summary|
|He has three healthcare patents and seven peer-reviewed scientific publications.|
|Expert Witness Experience|
| Expert acted as coordinator and/or as an expert witness in several successful Judicial Reviews concerning U.K. reimbursement of drugs and devices. Currently acting as expert witness in the determination of drug device issues.
Member of the expert witnesss Institute
|Training / Seminars|
|Has given several seminars on wound care products and compression hosiery products|
|Expert has experience locating vendors of clinical trials, stability testing, drug product testing, pharmaceutical reformulation, pharmaceutical distributors, placebo manufacture, sterilization processes, medical expert reports, bulk active ingredients and excipients, and market research.|
|Expert is the CEO of a firm that will act as an EU Authorized Representative for drugs, devices, cosmetics, and IVDs.|
|Other Relevant Experience|
|Will act as non-executive director of US pharmaceutical and or medical device companies that need international experience of development, registration and reimbursement issues.|
|German||Expert has near fluent skills in German. In addition, he regularly advises clients in Germany, France, Italy, Sweden, Denmark, Iceland, and Hungary.|
|French||Expert is near fluent in French.|
Fields of Expertise
European drug registration, in vitro diagnostics, CE Marking, foreign medical device regulation, In Vitro Diagnostics Directive 98/79/EC, United Kingdom healthcare expense reimbursement, Current Procedural Terminology, animal vaccine, herbal product, medical device product development, European marketing, strategic planning, ISO 9000 implementation, acquisition, drug dosage form development, drug labeling requirement, drug product approval, drug regulation, drug stability, drug testing statute, European patent, European statute, health care industry quality management, health care system, medical device, medical device process validation, medical device product improvement, medical device reliability testing, medical device testing, medical device reporting, Medical Device Reporting regulation, over-the-counter drug regulation, pharmacoeconomics, strategic market planning, wound healing, European Union Authorized Representative, health care marketing, United Kingdom borderline substance, United Kingdom medical device reimbursement, European Community Sixth/Seventh Amendment, European Inventory of Existing Commercial Chemical Substances, European labeling requirement, European manufacturing, European safety directive, European safety standard, FDA medical device regulation, food, oral surgery, orthodontics, pediatric dentistry, preventive dentistry, dosage, adverse drug reaction, medical reimbursement, herbal toxicity, product pricing, marketing mix, European market research, pharmaceutical technology, European electrical standard, bulk drug, over-the-counter topical drug product development, over-the-counter drug product development, pharmaceutical manufacturer, drug formulation, pharmaceutical research and development, pharmaceutical product development, in vitro toxicology, stability testing, medical device auditing, drug validation, drug clinical trial, biotechnology assessment, medical device clinical research, pharmaceutical product formulation, pharmaceutical intermediate, drug safety testing, pharmaceutical quality assurance, pharmaceutical research, medical diagnostics, drug development, pharmaceutical industry, biotechnology quality assurance, biotechnology market research, drug analysis, medical diagnostic test development, European standard, pharmaceutical quality control, European Committee for Standardization, drug delivery, medical device manufacturing, medical device design, pharmaceutical drug, sunscreen, pharmaceutical manufacturing, over-the-counter drug, drug screening, bulk pharmaceutical chemical manufacturing