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Director Global Regulatory AffairsAdvanz Pharma
Senior Vice President & Head Global Regulatory Affairs, Mankind Pharma
Director Global Regulatory Affairs
Senior Vice President & Head
Global Regulatory Affairs, Mankind Pharma
Principal RAAHA LLC and Former FDA
EVP & Head GRPD CentersPoland, India, Egypt and Mexico, Glaxosmithkline Pharmaceuticals Ltd
Vice President and Head Corporate Quality ControlDr. Reddy's Laboratories
Chief Executive OfficerSouth African Health Products Regulatory Authority
Quality Assessor API Registration DepartmentANVISA
Executive EditorPink Sheet
Deputy Director, Licensing DivisionMedicines and Healthcare products Regulatory Agency (MHRA)
Vice President - Quality and RegulatoryEISAI India
Head of Regulatory Affairs, EuropeAdvanz Pharma
Head - Regulatory AffairsSerum Institute of India
Vice President, Technical - Regulatory & AccessParexel International and Former FDA
Vice President & Head - Global Regulatory AffairsAlembic Pharmaceuticals
Director - Regulatory Affairs and Head Medical Device and India RegulatoryCipla
Senior Vice President & Head - Global Regulatory AffairsMankind Pharma
President-Global Quality, Medical Affairs & PharmacovigilanceCipla
Senior Vice President - Quality and RAPiramal Pharma Solutions
Sr. General Manager - Advanced Biotech LabIPCA Laboratories
Adjunct Professor - University of Illinois and University of Houston and FounderKaryo Biologics, Adello Biologics and Pharmaceutical Scientist Inc.
RAAHA LLC and Former FDA
Aloka Srinivasan, Ph.D. is currently the Vice President and Head of Regulatory Practice at Lachman Consultants. Prior to joining Lachman, Dr. Srinivasan was the Vice President of Regulatory, Lupin Pharmaceutical Inc. Dr. Srinivasan worked in FDA prior to joining industry as a team leader and Acting Director at Office of Generic Drugs and spearheaded the establishment of the DMF review division in CDER based on GDUFA and worked on the regulatory criteria related to complex APIs. Dr. Srinivasan was one of the architects of the QbR-QOS and took part in the QbD initiative of CDER Dr. Srinivasan is also the representative of International Generics and Biosimilar Medicines Association (IGBA) in ICH Q11 Q&A Implementation Working Group (IWG). Prior to joining FDA, Dr. Srinivasan was a senior scientist at National Cancer Institute (NCI) and did her Ph.D. at University of Missouri, Columbia. Her thesis involved studying of intermediates in activation of nitrosamines in cosmetics and drugs.
EVP & Head GRPD Centers
Poland, India, Egypt and Mexico, Glaxosmithkline Pharmaceuticals Ltd
Vice President and Head Corporate Quality Control
Dr. Reddy's Laboratories
Chief Executive Officer
South African Health Products Regulatory Authority
Quality Assessor API Registration Department
Deputy Director, Licensing Division
Medicines and Healthcare products Regulatory Agency (MHRA)
Keith McDonald joined the Medicines Control Agency (now MHRA) in 1997 and was appointed to the position of Deputy Director of Licensing Division in 2015. Responsibilities include; new marketing authorisations, scientific advice, clinical trials and parallel imports. The Licensing Division is also responsible for the Early Access to Medicines scheme and the MHRA Innovation Office. He has held responsibilities as theUK delegate at the Coordination Group for Mutual Recognition and Decentralised procedures (human) and was the regulatory rapporteur for ICH Q11 on the development and manufacture of drug substances for human medicines.
Vice President - Quality and Regulatory
Head of Regulatory Affairs, Europe
Head - Regulatory Affairs
Serum Institute of India
Vice President, Technical - Regulatory & Access
Parexel International and Former FDA
Mr. Crooker is a valuable, scientifically trained drug development attorney with a highly desirable combination of U.S. Food and Drug Administration (FDA) and private sector experience in global large-cap, mid-size specialty and closely held pharmaceutical and biotechnology companies. Mr. Crooker has accumulated extensive global professional and practice experience for 21 years in applying laws, regulations, and policy to successfully solve complex problems confronting pharmaceutical and biotechnology firms engaged in all stages of product development; chemistry, manufacturing and controls (CMC) and product quality strategy; the regulatory approval process and health authority engagement; product commercialization and lifecycle management; and drug manufacturing compliance and enforcement for both conventional commercial manufacturers and compounding pharmacies.
Mr. Crooker readily identifies, analyzes and capably resolves complex legal, regulatory, and technical issues in a high risk and heavily regulated environment. Mr. Crooker has a proven record of effectively counseling and communicating with organizations on the analysis of issues at the interface of product development and commercialization, regulation, and business; creating successful technical, regulatory and compliance strategies for all stages of pharmaceutical product lifecycle management; assessing and integrating new product acquisitions; and leading and growing business functions
He has presented at numerous meetings for the American Association for Pharmaceutical Scientists (AAPS) and participates in the International Society of Pharmaceutical Engineering (ISPE), the Food and Drug Law Institute (FDLI) and the American Society for Testing and Materials (ASTM).
Mr. Crooker holds an undergraduate degree in chemistry and a law degree. He remains an active member of the California Bar and has also been admitted to the U.S. District Court for the Central District of California.
Vice President & Head - Global Regulatory Affairs
Director - Regulatory Affairs and Head Medical Device and India Regulatory
Senior Vice President & Head - Global Regulatory Affairs
President-Global Quality, Medical Affairs & Pharmacovigilance
Dr. Ranjana Pathak isPresident -Global Quality, Medical Affairs & Pharmacovigilanceat Cipla.Ranjana has previously held leadership roles in pharmaceutical companies such as Actavis, Endo Pharmaceuticals, Zenith Goldline and Thames Pharmacol.
Ranjana has a Doctorate in Health Administration from the University of Phoenix, USA; an MBA from Dowling College, New York; a Post-Graduate Diploma in Pharmaceutical & Chemical Analysis from Sophia College, Mumbai; and a B.Sc. (Hons) in Chemistry from Mithibai College, Mumbai. She has received training in leadership in pharmaceuticals and biologics at Harvard University.
As a Member of the Management Council at Cipla, Ranjana leads the organisation’s worldwide quality enterprise from the development of a product to its commercialization, and spearheads Cipla’s commitment to an uncompromising state of control with absolute regulatory compliance across all manufacturing sites of Cipla, its partners and third parties
An industry veteran, Ranjanahas over three decades of experience in pharma and brings to the table extensive industry experience in dealing with regulatory bodies around the world. In 2006, Ranjana received the Rising Star award from the Healthcare Business Association. In 2018, she was recognized as Woman Leader of the Year award at the Future Leaders’ Summit. In 2019, She received the National Healthcare Leadership Women Award presented by Zee Business.
Senior Vice President - Quality and RA
Piramal Pharma Solutions
Sr. General Manager - Advanced Biotech Lab
Sanjeev Gupta has obtained Ph.D. in Molecular Biology/Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as Sr. General Manager and Head, Advanced Biotech Lab (R&D-Biosimilar), Ipca Laboratories Ltd., Mumbai, India. Sanjeev Gupta has established a new world class state of the art Biotech R&D facility for the development of mAb Biosimilars. He is also actively involved in establishing modern, lean and multiproduct flexible single use Bio-manufacturing facility for Biosimilar clinical trials and commercial launch.
He carries around 20 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies. His core expertise lies into Molecular Biology, Cell Line, Upstream process development, Bio-analytical as well as GMP cell banking and characterization.
Till date, he developed and contributed for over twelve recombinant molecules, of which eight Biosimilar products has been already launched in the Indian market and the rest are in the developmental or clinical phase, and are expected to be launched in near future.
During his professional tenure, he worked at various position in reputed Indian biopharmaceuticals industries such as Zydus-Ahmedabad, Wockhardt-Aurangabad, Panacea-New Delhi, Intas-Ahmedabad and at present in Ipca Laboratories, Mumbai.
He delivered talks on Biosimilars in various national and international conferences organized by IBC, Terrapin, BioTrain, IMAPAC, CphI, Biopharma, Informa, Selectbio and UBM.
He has also published several Research articles (11), Book chapters (05), Magazines (06) and Patent (01) in lieu of the Biosimilar development.
Adjunct Professor - University of Illinois and University of Houston and Founder
Karyo Biologics, Adello Biologics and Pharmaceutical Scientist Inc.