About Global Pharma Regulatory Summit

CPHI Conferences and Informa Markets in India is delighted to announce the 13th Annual Edition of Global Pharma Regulatory Summit from 19th - 21st June 2024 in Mumbai. A premier pharma regulatory event for the Indian generics and biosimilars industries, featuring timely program with relevant technical and regulatory agenda.

This summit will bring together regulatory operations and submission professionals to learn best practices in the compilation, formatting, and submission of a variety of approval applications. Top officials and subject-matter experts will share their knowledge and best practices to enhance attendees understanding of how to succeed in generic and biosimilar development, the regulatory process and approvals and the evolving policy landscape.

Key Topics

Global pharma regulatory harmonization with technological innovation

SAHPRA - South African Health Products Regulatory Authority

EU Regulatory update


Regulatory Considerations for Real World Evidence (RWE) and Big Data: Ensuring Data Quality, Integrity, and Validity

AI Reinventing Pharma Regulations

GMP - Annex One Guidance - ANVISA

Bio-similar US vs EU (FDA vs EMA) - Can it be interchanged

Bio-similar US vs EU (FDA vs EMA) - Can it be interchanged

Quality Risk to Pharma development use cases- ICH Q9 to ICH Q12

Summit Speakers 2023

Glimpses & Testimonials