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In Vitro Diagnostics Directive 98/79/EC


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European Union Experts

The following experts are available as European Union consultants and European Union expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  European Union - An economic and political union of 27 member states, located primarily in Europe. It was established by the Treaty of Maastricht on 1 November 1993 upon the foundations of the pre-existing European Economic Community.

Synonyms:  EU

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European Union Experts
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Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), USA

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), USA

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile

Québec, Canada

Expert in Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction
Expert has 25 years experience in pharmaceutical process scale-up, wet granulation end-point determination, compaction and tableting. He has published many articles on these topics, edited "Pharmaceutical Process Scale-up" handbook, and wrote chapters in ... See full profile

New Jersey (NJ), USA

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

Expert in Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP's/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international ... See full profile


Expert in EU GMP and Quality Systems
Educated to bachelors degree and masters level in biochemistry with many years experience in this field educated to bachelors degree level with many years experience in the ... See full profile


Expert in Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing the ... See full profile

Brussels, Belgium

Expert in Manufacturing, Automation, Engineering Design, Operations, Control Engineering, Food Factories
Long-standing designer of complex factory automation systems. Expert witness work has involved determining causes of program failures that have led to serious factory fires and equipment failure, as well as failure to perform to specification. See full profile

Devon, United Kingdom

Expert in International Marketing (Europe, CEE, SE Asia, Gulf States)
During his long career in business, Expert searched, travelled and learned a lot about many peoples and their enterprises. He knows that he is well-organized and has suitable qualifications to help companies to achieve great success in the global ... See full profile

., Poland

Expert in Chemical Regulations and Safety
Toxic substance control act (tsca) regulations. Expert has extensive experience in helping clients comply with regulations under TSCA since initial promulgation in 1977. His current consulting service organization emphasizes chemical ... See full profile

Pennsylvania (PA), USA

Expert in Parental Alcohol, Drug or Mental Health Problems, and Effects on Children and Other Family Members
Expert has extensive experience in the fields of both substance misuse and its consequential effects on both those who misuse substances and their families; and on mental health difficulties and their consequential effects on families. See full profile

Somerset, United Kingdom

Expert in Energy, Oil & Gas--Resources, Global Market & Geopolitics | USA, EU, Latin America, China, OPEC
Expert's expertise is the global, market-centered oil-and-gas (O&G) system including both (1.) Consuming and (2.) Producing states: -1.a- Producing countries' O&G sectors. For example OPEC in Latin America (especially Venezuela and Brazil) and OPEC in the ... See full profile


Expert in Intelligence Research Analysis
Policy Legislation formation. Research and Development. General political Advisor. Intelligence analysis, Forensics Intelligence. Computational Forensics. Data Mining. Lecturer. ( Mineral Forensics). Special operations. Risk Management and Enhanced Due ... See full profile

Uccle, Belgium

Expert in Computational Electromagnetic Modelling and EMC, Signal & Power Integrity, Remote Sensing, Microwave
Expert Nadir Expert worked as research manager (5 years) and principal scientist (2 years) at Nokia for 10 years. His research managerial tasks include line (resource) management, conducting internal research projects, university & EU (European Union) ... See full profile


Expert in Health Conditions for International Trade in Fisheries Products, Food Safety, and EU Fisheries
Expert has worked in the Instituto Nacional de Pesca of Ecuador, developing industry codes of practice for processing and handling of farmed and wild-caught shrimp and shrimp products. Assisted with the design and implementation of ... See full profile


Expert in Veterinary Epidemiology, Salmonella, Diarrheal Disease, Antimicrobial Resistance
Expert is a veterinarian with expertise in food animal production, Salmonella, E. coli, antimicrobial resistance, epidemiology and public health. She has experience in large animal practice, veterinary animal and public health legislation, public health ... See full profile

Vlaams Brabant, Belgium

Expert in Construction Materials, Heavy Clay Products, Clay Bricks, Roof Tiles
He managed the technical research center of the French heavy clay industry and has written wrote a book on manufacture of clay bricks and roof tiles. He knows quite well how to develop new product and how to solve production and quality problems. See full profile


Expert in Drug Regulatory Affairs (European Union)
Expert has nearly 20 years experience in Drug Regulatory Affairs (RA). Before setting up his own RA consultancy in June 2008, he has worked in various senior RA positions in the pharma and biotech industrie having been located in Germany, the UK, ... See full profile


Expert in Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, ... See full profile

Colorado (CO), USA

Expert in Regulatory Affairs for Cosmetics, Fragrance, Health Products, Good Manufacturing Practices
Expert has been nominated in 2009 as a National Court Expert in Paris (Chemicals – Cosmetics – Perfumes and Cosmetic Good Manufacturing Practices) He became licensed as well in 2009 on toxicological and safety evaluation for cosmetic products ... See full profile


Expert in Environmental Compliance, Pollution Prevention, Health and Safety, and Fire Loss and Prevention
Expert has extensive practical knowledge and experience in the field of pollution prevention technologies. He has performed numerous pollution prevention audits internationally resulting in millions of dollars in waste minimization, ... See full profile

West Virginia (WV), USA

Expert in EU Environmental Policy and Law: Environmental Impact Assessment; Water and Waste Management
Expert has achieved skills in providing enterprises with decisional support to manage waste concerns and to integrate them into operational activities. His claim is to follow up the European waste policy and to point out the potential needs for ... See full profile


Expert in Organic and Medicinal Chemistry
Expert has expertise and broad knowledge in Synthetic Organic Chemistry of various classes of compounds coupled with experiences and adept characterizing compounds using various NMR techniques 1-D and 2-D (COSY, HMBC, TOCSY, ROESY) diverse ... See full profile

Florida (FL), USA

Expert in Organic Chemistry, Chromatography, Spectroscopy, Pesticide Analysis, Sugar Cane and Editing
Expert is an expert in organic chemistry. While working on his projects, he synthesized various organic molecules. His project on the production of bio-plastics from sugarcane biomass attracted a research grant of € 934,500 from the ... See full profile


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