7^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR September 25-26, 2017 Chicago, Illinois, USA

Eliana Silva de Moraes has her expertise in food and drug law. Twenty Six years experience helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents. Played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA in order to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes. Member of the Brazilian Bar Association and The Portugal Bar Association. Speaks Portuguese, English, French and Spanish.

Food and Drug Law, Regulatory guidelines, Pharmaceuticals

Dr. Silay serving as the Chairman of Labiopharma, LLC in US, providing clinical trial administration, market access, medical writing, patient recruitment, retention, regulatory and medical affairs support, drug repositioning for hospitals, academic institutions and pharmaceutical companies from preclinical to post marketing stages for several years. Dr. Silay is also providing comprehensive and strategic consulting services for the approval of Drugs and Medical Devices and attended several meetings with FDA, EMA, Health Canada and Turkish Health authorities and social security institute.Dr. Silay in US, most recently worked as the Vice President, Medical Affairs, and head of Medical Affairs Neurology in the US headquarters Basking Ridge, New Jersey reporting to the President and CEO of Ipsen North America where he was key in building a Neurology Franchise by hiring many employees. Dr. Silay is a senior consultant, project manager, executive physician scientist, certified clinical research professional in the healthcare ( pharmaceutical, medical device, hospital chains) industry with an Executive MBA degree from the Olin Business School at Washington University in St. Louis which is ranked #2 in United States of America by Wall Street Journal in 2010. Dr. Silay is a member of American Academy of Neurology, chief editor of Journal of Developing Drugs, an editorial board member of Expert opinion on Emerging Drugs, a current ad-hoc reviewer at the NIH ( National Institute of Health) and NINDS, past speaker at DIA ( Drug Information Association) and member of DIA SIAC’s for Good Clinical Practice/Quality Assurance Special Interest Activity Community (GCP/QA SIAC), Clinical Trial Registry/Results Disclosure Working Group (CTR/RD Working Group), Natural Health Products. , MDS (Movement Disorder Society) , current secretary general of HEPA (Health Economics& Policy Association), charter and previous president of AMSA (American Medical Student Association) Turkey, previous president of SOCRA (Society of Clinical Research Associates) in New Jersey, board of directors member at the SoPE and founder of SoPE(Society of Physician Entrepreneurs) Turkey chapter. Dr. Silay is a recognized senior consultant executive in the public health, PPP, health economics and pharmaceutical industry with a track record of conducting successful, carefully designed outcomes trials as well as randomized double blind placebo controlled clinical trials in CNS (Central Nervous System) therapeutic area such as Parkinson’s, MS (Multiple Sclerosis), Stroke, head trauma, Fibromyalgia, Tourette syndrome, Alzheimer’s disease as well as Pulmonary Critical Care/ Lung transplant, Cardivascular (Cardiac stent, MI, Ambulatory Blood pressure monitoring trials) and Oncology therapeutic areas. Dr. Silay, a dual citizen of U.S.A. and Turkey was born in Turkey and educated in Turkey, Germany and U.S.A. He completed his medical School at The University of Ankara in Turkey and his internship at Baylor College of Medicine and University of Texas in Houston, Texas. He attended a Physician Scientist Training Program at The MD Anderson Cancer Center of University of Texas. Dr. Silay worked on projects with several Pharmaceutical companies such as Astellas, Chiron, Fugisawa, Nabi Biopharmaceutical, Forest Pharmaceuticals, KV Pharmaceuticals, Medtronics, Deep Breeze, Teva, Ipsen as well as governmental organizations such as NIH, Chest foundation, American heart association grants, FDA, Turkish minister of Health and the World Bank As a prolific scientific writer he published extensively with more than 15 peer reviewed article and more than 100 platform and abstract presentation at the academic and industry level in national and international meetings. Dr. Silay is currently serving as the Chairman of the Istanbul Consulting Group (ICG) . He provides guidance and support to Turkish Ministry of health through World bank project. As the former General Manager of the largest distributor of Siemens healthcare company with ~220 employees, he played key role in developing mobile Breast cancer screening program for Turkish and Syrian refugees in Turkey. As a BioPharma CEO, Carveout, Turnaround Specialist he is known as, Entrepreneur Doctor & "International Healthcare Executive (Pharmaceutical, Hospital Chain, Diagnostic & Medical Device)", Management Consultant, "Business, Strategy, Marketing Savvy Physician. He has Proven ability to build high performing teams and productive organizations, turn around brands, and build revenue in diverse markets. As the former director, Market Access & Health Policy for AIFD( Research Based Pharmaceutical Companies) which the 40 members represent all major global pharmaceutical companies, 650 billion dollars of 1 billion dollar Global Pharmaceutical market. He represented pharmaceutical companies and was in discussion with all ministerial levels, including ministry of health, finance, labor, development and science& technology in Turkey.

Neurology, Pulmonary Critical Care, Rheumatology, Oncology and related therapeutic areas within academics and industry. regulatory processes, identifying and addressing risk management issues throughout lifecycle, presentation development to large payers, safety monitoring, designing and conducting clinical trials.

Royth v. Hahn leads the TÜV SÜD Business Unit “Medical and Health Services” in the NAFTA region and manages the technical topics of functional safety and software for medical devices globally. He also leads the “investor’s program” with services of technical and regulatory due diligence. He started his career at the University of Bonn and a MedTech spin off/start up in the field of medical ultrasound. He was head of a test laboratory and interim professor at a university of applied sciences in Germany for the topics of signal processing, medical imaging and ultrasound technology. Prior to taking on management positions within TÜV SÜD, Royth worked as Senior Product Specialist for ultrasound devices and lead auditor for active medical devices and software. He is member of several national and international standardization committees. Royth holds a masters degree for physics from the university of Bonn (Germany), and industrial engineering & management in Koblenz (Germany). He also holds a PhD in electrical engineering from the University Duisburg in Germany.

Functional Safety for medical Devices, Medical Software including big data analytics, deep learning, medical imaging, IT security for medical devices, ultrasound technology

Ed Israelski PhD, consultant, is retired director of human factors at AbbVie, since 2001, where he led a cross-division team and managed an R&D group to imbed best-practice human factors engineering HFE design methods into all of AbbVie's products, to ensure safety and usability. He was responsible for corporate HFE policies and guidances and internal HF education. He is past co-chair of the Human Factors Committee for the AAMI Standards organization and co-convener of the medical device Usability Engineering groups for the international standards organizations ISO and IEC. He is a board Certified Human Factors Professional and a Fellow of the Human Factors and Ergonomics Society.

Regulatory Affairs, Intellectual Property Rights

Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Medicines He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, Other ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology -Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organizations. Dr Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany. and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP

Dr. Michel Mikhail’s area of expertise is Non-Clinical Pharmacology and Toxicology as well as Global regulatory Affairs and Regulatory Agencies Interaction. In particular interaction with the US-FDA, the EU_EMA as well as National Agencies in Europe such as UK-MHRA, German BfArM and PEI, France’s ANSM, Sweden’s MPA, among others, interaction with Japan’s PMDA and Emerging markets Agencies. Dr. Michel Mikhail is an Expert in Biosimilars. He is Interested in Immuno-Oncology, Regenerative Medicine, in vitro and in vivo Animal modeling, and mechanisms of Action associated with diseases and regenerative medicine.

Dr. D. Figueredo received her B.A. degree (1995, Biochemistry) from Faculty of Biology, Havana University, Cuba, and both her MSc (1995, Biomedicine) and PhD (1999 Pharmaceutical Sciences) degree from National Center for Scientific Research in Havana, and most of the results were done in the Department of Toxicology at the Free University in Amsterdam. Postdoctoral training in Molecular Toxicology and pharmacology was completed at the Faculty of Pharmacy in Toronto, Canada. She is currently the Vice president of Cuban Pharmacology Society. At present she works in the Cuba Regulatory Agency, she is one of the reviewers for authorization of clinical trials. She is the project leader about Pharmacogenetic guideline. She belongs to Iberoamerican Pharmacogenetic network (RIBEF) since 2008; she has been speaker of this topic in several international and local scientific meeting. Recently, she got the Master in Clinical Trials.

She has been referee of scientific journals. Other previous academic appointments include lecturer in different international meeting. She has been the recipient of National Award of Pharmacology twice from the Cuban Pharmacology Society. She worked as Expert for the evaluation of preclinical platform in South Africa. (CSIR). Dr. Remirez research is described in over 30 published research reports.

A life sciences professional with experience in manufacturing and quality departments. Moved up the ladder as Vice president and later as Head-Quality and gained experience in Quality systems, Projects, operations management. These experiences gave me opportunities and immense knowledge, opportunities to prove and validate my capabilities in Man management as well as all aspects of lifesciences Present job profile has added knowledge and experience in international best practices in quality systems, project and operational management for running an organisation. A Certified Internal auditor for ISO 13485, ISO 15189 quality systems , experienced in ISO 14971, Risk Assessment, ISO 62034. International experience as Consultant for QMS systems for Biotech Company Member of team as Subject matter expert for due diligence in-vitro Diagnostics Company. Experienced in regulatory approvals as per CDSCO guidelines, WHO of human vaccines and CE guidelines for medical devices –IVD reagents and equipments

Vaccine process optimization and development and IVD Product development