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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.
Global pharma regulatory harmonization with technological innovation
SAPHRA - South African Regulatory Update
EU Regulatory update
ClinTrials- ClinOps REGULATORY PANEL
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
Quality Risk to Pharma development use cases- ICH Q9 to ICH Q12
Access the latest information and insights on global regulatory affairs program
Analyze how stakeholders around the world are supporting regulatory system optimization
Examine the impact of new initiatives for emerging markets
Network with innovators and opinion leaders in the pharma regulatory affairs arena
Global Director - Regulatory AffairsAdvanz Pharma
Head – RegulatoryLupin
Head GRPD Centers – Poland India, Egypt and Mexico, Global Regulatory Platforms and Delivery (GRPD), GlaxoSmithKline
Director - APAC Analytical Tech, Global Tech and Engr group. Pfizer Inc.
Global Regulatory SciencesPfizer Healthcare India
Managing DirectorGSK Pharmaceuticals India
Director International Government and Regulatory Engagement, US Pharmacopeia
Chief Quality Officer - Global Quality & Regulatory AffairsSai Life Sciences
Director DPDAI Governance IntegrationsNovartis
Deputy Director Standards and ComplianceMedicines and Healthcare products Regulatory Agency
Vice President – PSAIDr. Reddy's Laboratories Ltd.
Division Head - Regulatory affairsOtsuka Pharmaceutical India Private Limited
Managing Director and South Asia HeadBayer Zydus
Deputy CollectorGovernment of Gujarat
Industry Expert
National ChairClinical Pharmacology Indian Council of Medical Research Govt. of India. & Member, Drug Statistics Methodology Committee, WHO
Head Regulatory Intelligence and ReportingAdvanz Pharma
Associate Vice President-Regulatory AffairsAmneal Pharmaceuticals
Sr. Vice President & Head Global Regulatory Affairs, Mankind Pharma
Vice President & Head-Advanced Biotech (Biosimilar)Ipca Laboratories Ltd.
Director Regulatory affairs, Dr. Reddy's Laboratories
Country DirectorUSFDA India Office
Senior Vice- President - Clinical Development & Medical AffairsHetero Labs Limited
PresidentOPPI, Managing Director & General Manager, AbbVie India
President Indian Pharmaceutical Association (IPA)
Head API regulatory sciencesBiocon
The content was as per the topics and well-drafted by all the speakers. The agenda was well organised and there was sufficient time for people to connect. The conference was well organised and as per the experience of the previous editions, this was the best.
Ramesh Bhukan Commercial Quality Head, Johnson & Jhonson
I would like to take a minute and thank all speakers for providing insightful information. Very good and Nicely organized Virtual 10th Annual Global Pharma Regulatory submit
Shikha Mishra Regulatory Professional, Novo Nordisk India
I am very happy to say that this event was very effective and full of learning. Very warm thanks to the Organizing Committee. It is really very helpful for all the pharma industry to collaborate the regulatory practice
Abdullah Arif Regulatory Senior Executive, Global Regulatory Affairs, ACME Laboratories
Despite the new normal, we have quickly adapted, collaborated and engaged ourselves. The session is really splendid and the organizers of Inform pharma markets are sincerely appreciated. Thank you all.
Karthik Nooney Regulatory Professional I, Novo Nordisk India
I found it a very highly interesting conference with a packed agenda, imminent speakers delivering valuable insights and it's a great opportunity to meet likeminded people to share knowledge and new ideas
Anmol Arora Regulatory Coordinator, Novartis
The platform was very user friendly, could easily navigate and connect with various colleagues having different knowledge at different levels. It was a very good opportunity to learn from speakers as well and get their opinions about the doubts.
Kavitha Chindanooru Sr. Regulatory Professional, Novo Nordisk India
I think the way sessions were organized was excellent in the sense there were networking sessions and the activity to carry out individual meetings between the sessions. With regards to the speakers, I think they were excellent in their presentations and are very experienced in their areas. The information they have provided was very high level which is useful to large audiences. I was very happy with the way the conference went.
Dr. May Tahhan Regulatory Affairs Manager - ANZ, Strides Pharma Science
Full speaker list • Full conference agenda
Full speaker list