About Global Pharma Regulatory Summit

The evolving regulatory landscape for the Pharmaceutical, Biotech and Medical technology has been put on full throttle with digital innovation. Digital transformation, Patient Safety, extended medical access &, improved quality standards etc. for a holistic healthcare system is driven by key Regulatory authorities and agencies aiming to harmonize and revolutionize scientific collaboration and reliance on standards & quality. The 11th Annual Global Pharma Regulatory Summit is set to encore its successful execution of last year with more dialogues and guidance from Key Regulatory Authorities, Industry Experts and Agencies globally, strengthening collaboration, convergence, and reliance on regulatory systems for medicines and other health technologies.

Program Focus

IDMP – Regulator and Industry perspective

Regulatory intelligence and its long-term benefits in pharmaceuticals

cGMP inspections amid COVID-19 pandemic

FDA safety information and adverse event reporting program

Understanding new FDA, EMA & PDMA regulations in drug & medical devices

Australia / New Zealand – submission pathways

Regulatory due diligence at the time of Mergers & Acquisitions

ICH Q12CMC regulatory spotlight for biologics & biosimilars

Summit Speakers

Glimpses & Testimonials