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Vice President & Head - Global Clinical Management at Dr.Reddy's Laboratories, India
With medical background, Dr. Chachad has extensive experience in clinical development of new healthcare products including innovative drugs, complex generics, branded generics, biosimilars and even vaccines. This includes providing strategic leadership in clinical & medical affairs by designing clinical registration strategy and executing studies for global submissions worldwide, as well as taking up medical initiatives for new medicinal product launches. His expertise includes clinical regulatory consulting for NCEs, NDAs, complex generics and even vaccines. His understanding of global clinical requirements has yielded successful product registrations in most regulated markets across the globe including EU and US. He also has a robust pharmacovigilance experience in clinical trials era as well as in post-authorisation setting. He has comprehensive theoretical and practical knowledge of the legal and regulatory requirements surrounding global pharmacovigilance. His audit experience includes over 100 audits for pharmacovigilance, bioequivalence & clinical studies at sites located worldwide. While he has represented his clinical and nonclinical expertise at 40+ scientific advice meetings including EMA, MHRA, FDA, TGA and WHO, he has been clinical and nonclinical signatory to 1000+ expert reports and authored many scientific publications over the last decade.