6^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sept 29-30, 2016 Orlando, USA

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives.

GMP training,medical devices

Boyd L. Summers has completed his Bachelor of Science (BS), Business Administration at Weber State University, USA. Areas of emphasis: Information Systems, Production and Operations Management, Quantitative Analysis and Methods, Human Resources, Economics, Business Management and Statistical Analysis and Computer Science.He is currently working as a Software Engineer – Quality for The Boeing Company and a Software Technology Consultant for BL.Summers.Consulting.LLC located in Seattle, Washington. With 30 years of experience in Software Engineering and a leader of multiple software development teams, Boyd continues to solve complex technical challenges to ensure that system and software engineering problems are addressed, resolved and compliant. Author of the two software technology books titled; “Software Engineering Reviews and Audits.” and “Effective Methods for Software and Systems Integration. Provide Software Articles to Software Engineering Journals and magazines. Topics include: System Design, Software Requirements, Software Design, Software Test and Evaluation, Configuration Management, Quality Assurance, Process and Product evaluations. Applies Processes in Agile, Lean and Six-Sigma including a Software Technology Speaker at conferences and member of the American Society Quality (ASQ).

Quality Assurance

David Amor, MSBE, CQA is a medtech/ biotech consultant and mobile health entrepreneur who founded Medgineering, a company focused on remote compliance, regulatory & quality systems consulting for larger companies and start-ups alike. A graduate of the prestigious Innovation Fellows program at the University of Minnesota’s Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and a 35 Under 35 Entrepreneur in 2015 by MN Biz Magazine. Recently, David co-founded and helped launch Remind Technologies, a Texas based mobile health company developing smartphone based remote medication management system (www.remind-technologies.com). He also is co-inventor on several issued utility patents and co-pioneered a disruptive e-consulting platform for the medtech and pharma industries called QuickConsult (www.myquickconsult.com). Lastly, David also serves as an adjunct professor at St. Cloud State University in Maple Grove, MN where he teaches courses on risk management and design control. The current focal points of his consulting practice are specializing in risk management, design controls, combination products and mHealth.

Regulatory Affairs and Risk Managment

Mohammed R Khan is a Quality Management Consultant and Principal, Synergex Consulting, Canada. He has earlier directed the QA/QC and Regulatory Compliance operations at DuPont Pharmaceuticals Canada, and served on the Board of Directors at the Pharmaceutical Manufacturers Association of Canada / Plant Operations Section. As an active member of the Drug Information Association, he has served on the DIA Advisory Council of North America, Chaired the DIA Canadian Programming Steering Committee, and was responsible for initiating and establishing the DIA’s Annual Canadian Meeting. He has also served as Program Coordinator, Program Committee Member, Session Chair and Speaker at numerous DIA events spreading over the US, Canada, Europe and South Asia, and is a recipient of the DIA Outstanding Service Award. He is a Senior Member of the American Society for Quality (ASQ) and also a Member of the Pharmaceutical Sciences Group (PSG) Canada. He has served as Presenter for the Parenteral Drug Association (PDA) in Europe and Japan, for the OMICS Group nationally and internationally as Organizing Committee Member and Speaker, and as a Presenter for the PSG Canada, International Quality and Productivity Center (IQPC) USA, UK based International Society of Ethnopharmacology, and the annual Indian Pharmaceutical Congresses.

Quality Management,Pharmaceutical Sciences

Dr. Elene Chikobava is a Master Chemistry, with 10 years of working experience as a biochemist in the Scientific-Research Centre of Biophysics and Biotechnology, where she has completed her PhD in Biologic Science. She became a senior specialist of the Pharmacopoeia Committee of Drug Agency of the Ministry of health, Labor and Social affairs of Georgia after its creation in 2003. After being actively involved in renovation of the Pharmacopoeia Committee, where she worked as a senior specialist of Pharmacopoeia Department. Then she started to work as a Head of Regulatory Affairs specialist for the domestic manufacturer of generic and herbal products - “Biopolus” Ltd (Georgia), along with it she was consulting Georgian wholesaler “GPC” about pharmaceutical products registrations of pharmaceutical products in Georgia and different companies; clinical researches and manufacturing technology. Dr. Chikobava had been a participant of numerous scientific conferences, including those conducted by WHO, she has published more than 20 scientific papers.

pharmaceutical,Regulatory Affairs

Dr. Mark Kindy is a biochemist/neuroscientist and Professor/Associate Dean for Research in the Department of Pharmaceutical Sciences in the College of Pharmacy at the University of South Florida and Senior Research Career Scientist at the James A. Haley VA Medical Center. He recently moved from the Department of Regenerative Medicine and Cell Biology and Neurosciences at the Medical University of South Carolina and a Senior Research Career Scientist/Deputy Associate Chief of Staff for Research at the Ralph H. Johnson VA Medical Center in Charleston, SC. He received his BS from the University of Massachusetts in Zoology and PhD from Boston University School of Medicine in Biochemistry. He was a postdoctoral fellow at the Salk Institute. Dr. Kindy started his faculty career at the University of Kentucky School of Medicine in the Department of Biochemistry and the Center on Aging.

His area of expertise is neurodegenerative disorders, animal modeling, mechanisms associated with diseases and regeneration of the brain.

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 has been referee of scientific journals related with natural products. 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). She is currently the Vice president of Cuban Pharmacology Society. She is the WHO focal point for traditional medicine in Cuba. At present she works in the Cuba Regulatory Agency, she is one of the reviewers for authorization of clinical trials, and the evaluation of safety and efficacy of drugs for registering. She is the project leader for Pharmacogenetic guideline. Dr. Remirez research is described in over 30 published research reports.

Pharmacology

Suresh Kumar Tannan Worked for about 25 years with Chambers of Commerce Industry Associations in various responsible capacities starting a career as a Research Assistant with Federation of Indian Chambers of Commerce and Industry, New Delhi And reaching the position of A Director of Asbestos Cement Products Manufacturers Association, New Delhi. Presently, working as an Assistant Professor of Economics, Lovely Professional University, Jalandhar, Punjab, India. He Worked as a Professor with International Institute of Business Studies, NOIDA for 2 years (2009-2011).He Worked as a Professor with the Institute of Productivity &Management, Ghaziabad for 2 years (2007-2009). He Worked as a Visiting Faculty with the Delhi University Indraprastha University, Ape jay Institute of Management Studies, New Delhi Institute of Management, YMCA Institute of Management, Indian Law Institute, Indian Society of International Law, APIC Institute of Health Care Studies, Delhi.

Prof. Dr. Rajiv Mahendru possessed Post-Graduate Degree in Obstetrics and Gynaecology from Himachal Pradesh University at the age of 29 years and became one of the youngest Professors. Presently, Head of the Department in the only second women medical college of India. He has 41 Publications in reputed journals and is the recipient of a prestigious Award for excellence in Medical field. Appointed as the Chief-editor of the Special issue of an international journal of repute and has numerous presentations to his credit at international arena as an invited Guest Speaker. He is the member of editorial board of international journals, Academic Board of many universities, member of recruitment for medical teachers, and assessor for establishing Medical colleges. He has chaired numerous sessions in the National and International conferences.

Medical and Drugs

He is chairman and managing director of Meher Pharma International. He has his an NGO, “Rab Di Meher” in Delhi to protect humanity .He has another NGO “Qabailee Naujawan” in Bihar to promote socioeconomic development and sports among villagers. He is author of Human Resource Management and Contemporary Human Resource Management. His article has been published in India and abroad on pharma exports and regulatory affairs He is chief editor in “Medicare News” a pharma newspaper. He is multicultural, multilingual and travelled in so many countries. He is global regulatory consultant and dedicated for pharma exports. He is a PhD Candidate.

Human Resource Management