Executive Vice President & Head - Global Clinical Management - Dr. Reddy's Laboratories
Clinical pharmacologist with 20 years of experience in medical affairs and global clinical development for registration of new drugs, complex generics, biosimilars and even vaccines
Strategic leader with success history of marketing authorisations granted worldwide for medicinal products across dosage forms and therapeutic segments
Medical Safety Leadership with comprehensive theoretical and practical knowledge of the legal and regulatory requirements surrounding global pharmacovigilance
Preclinical and Clinical regulatory consultancy and expert representation at the Scientific Advice Meetings with the heath authorities including EMA, MHRA, USFDA, TGA and WHO
Preclinical and Clinical Strategy Design for registration of conventional vaccines, multivalent “universal” vaccine and Covid products
Internationally acclaimed speaker at various seminars and conferences on clinical research and pharmacovigilance
Expert faculty in the functional areas of clinical development and pharmacovigilance at the teaching and training institutes, India, Czech Republic and Netherlands
Audit experience of over 100 audits including Clinical, BE and Pharmacovigilance audits Author of 25+ publications in scientific journals & congress presentations, and expert signatory for 1000+ clinical and nonclinical dossier modules
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