Speakers

Siddharth Chachad


Founder & Chief Strategist - Reguclin Consulting



➲ Clinical pharmacologist with over 20 years of experience in medical affairs and global clinical development for registration of new drugs, complex generics, novel biologics & biosimilars, advanced therapies and even vaccines


➲ Strategic R&D leader with success history of product development and marketing authorisations granted worldwide for medicinal products across dosage forms and therapeutic segments


➲ Translational Research, Medical Affairs and Drug Safety Leadership with comprehensive theoretical and practical knowledge of the legal and regulatory requirements surrounding global clinical development and pharmacovigilance


➲ Preclinical and Clinical regulatory consultancy and expert representation at the Scientific Advice Meetings with the health authorities including EMA, MHRA, BfArM, MEB, USFDA, TGA and WHO


➲ Internationally acclaimed speaker at various seminars and conferences on clinical research and pharmacovigilance


➲ Expert faculty in the functional areas of drug development and pharmacovigilance at the teaching and training institutes, India, Czechia and Netherlands


➲ Audit experience of over 100 audits including Clinical and Pharmacovigilance audits and expert signatory for 1000+ clinical and nonclinical dossier modules


➲ Author of 25+ publications in scientific journals & congress presentations, and a book chapter on Clinical Development in reputed Burger’s Medicinal Chemistry, Drug Discovery and Development, 8th Edition



Siddharth Chachad

Sessions


  • Thursday - May 11, 2023 - 14:00

    Global Clinical Development – Complex Generics

      Presentation


 

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