8th Annual Pharma Regulatory 2025

UTTAM C

08:30 – Coffee and Registration – An opportunity to meet and network with your conference colleagues.

UTTAM C

09:20 – Welcome Address & Opening remarks

RWE / RWD

UTTAM C

09:30 – Harvesting & Using RWE – Public, Private Partnerships to Bridge to Regulatory Requirements

•   Perfect methods of collecting, storing and analysing RWE
•   How do you ensure data is sufficient and support submission messaging?
•   Can we expect further integration of this type of data into submissions?
•   How can teams pivot to meet the demands of RWE and related submission changes?
•   Enhance data integrity - utilizing digital solutions to ensure that data across systems and documents is consistent, reliable, and ready for regulatory scrutiny.
•   The future of RWD RWE digital era

NEERAJ MARKANDEYWAR, General Manager - Medical Affairs, Sun Pharma

DIGITAL ERA

UTTAM C

10:00 – KEYNOTE TECH PANEL DISCUSSION - The Impact of Digitalization in Pharmaceutical Regulatory Affairs

•   How AI technologies are reshaping the landscape of compliance, risk management, and regulatory processes?
•   How industry expertise combined with advanced technologies, can enhance the reliability and trust (transparency, completeness, correctness, and timeliness).
•   Leveraging Technology in Clinical Research and Regulatory Affairs
•   Adopting to technological side for enhancing patient safety in recognizing early warning symptoms using advanced devices
•   Navigate digital transformation challenges - Strategies for successfully implementing computer assisted assessments in the regulatory processes, including global regulatory impact assessment.
•   Adding Value to Regulatory Operations with GenAI
•   Regulatory Innovation with AI: Balancing Progress and Compliance

Moderator
RASHMI HEGDE, Former Executive VP – Medical, GSK

Panellists
RAMANARAYANA PARHI, Vice President & CIO, Alkem Laboratories
NIVEDITA TELANG, Medical & Regulatory Director, Sanofi
SRINIVASAN ACHARY, Associate Director, Cipla
AMOL DESHPANDE, DGM Technology Transfer, Emcure Pharmaceuticals
GOPINATH MADHU, Senior Client Partner, Digital & Technology, Pfizer

UTTAM C

10:50 – Morning Coffee/Tea & Discussion

MEDICAL DEVICES

UTTAM C

11:20 – DISCUSSION WITH EXPERTS: Accessing the Indian Market – Current and Upcoming State of the Indian Medical Device Regulation

•   How organized can the approval of medical devices be? – Unfolding the complicated and time-intensive process which is simultaneously resource-consuming
•   Which pain points would industry like to see resolved?
•   Perspective from Pharmaceutical Stakeholders
•   Share evolving global, regional and country regulatory trends for medical devices
•   How to proactively update your quality management system with evolving regulatory requirements
•   With MDSW and AI/ML changing rapidly, what can we expect in the next 5 years for regulating these types of devices and diagnostics?
•   Manufacturing of domestic devices rather than depending on importing - Bearing in mind the differences between other nations' regulations
•   Regulatory streamlines and appealing expenditures considerations in the manufacturing of prospering medical devices

Moderator
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)

Panellists
SAILESH YHNB, Associate Director, RA Device Established Products, Novo Nordisk
VRUSHALI KHANDAGALE, Sr. Executive Regulatory Affairs, Fresenius Kabi
RUCHIR SHAH, Head Medical Devices Category, Regulatory & Safety Manager, Reckitt Benckiser
MANGALA KOTNIS, Former Head Regional Medical Affairs (MSL/ FME function), Abbott

UTTAM C

12:10 – Post Approval Changes: Frequent API Changes leading to DP Post approval changes - A complete overview for global markets

VANDANA SINGH, Head - API Regulatory Sciences, Biocon

UTTAM C

12:40 - Networking luncheon

REGULATING PHARMA

UTTAM C

13:40 – KEYNOTE PANEL DISCUSSION: Looking ahead to the future for new drugs:Regulating Pharmaceuticals in India to prioritise patient safety

•   How well are we doing with recent legislations?
•   With legislative reforms on the horizon, how does the future look for pharmaceuticals in India?
•   Expectations from industry / Cross-regional harmonisation
•   New challenges and considerations for regulators and the regulated entities
•   Which skills and tools do we expect to become more prevalent in the coming years?
•   Can industry and regulators alike prepare for these changes now?
•   Regulator’s Challenges in the Digital Era
•   Reduce Regulatory Complexity and accelerate patient access
•   Towards Instantaneous Approvals in 5 years: What would it take to get there?

Moderator
MILIND ANTANI, Leader, Pharma & Healthcare, Nishith Desai Associates

Panellists
MAYUR PARMAR, Drugs Inspector (Deputy Collector, Gujarat Government), FDA
GURPREET SINGH, VP, Managing Director Integrated Safety, IQVIA
AMIT PANDEY, Executive Vice President & General Counsel, GSK
GEETA SHANBHAG, VP - Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories
RAM BALANI, CEO / Founder, eSTARHelper (USA)
ROHINI PANDEY, Regional PV Head – SEA, Abbott
KRUPA BAHEKAR, General Manager, Emcure Pharmaceuticals

BIOSIMILARS

UTTAM C

14:30 - Global Regulatory Landscape of Biological molecules

•   Introduction to Biological and Small molecules
•   Overview of Regulatory framework for Novel/Biosimilar/generic molecule development
•   Regulatory requirements and interchangeability
•   Robust CMC package

SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare Disease, Novo Nordisk

UTTAM C

15:00 – Afternoon Tea/Coffee

CLINICAL TRIALS

UTTAM C

15:20 – DISCUSSION WITH EXPERTS: Unlock the secrets to mastering Clinical Trial Regulations - Mystery Un-Corded.

•   Clinical Trials - Regulatory Progress
•   DCTs: Opportunities and Challenges
•   PV in clinical trials and probing
•   Clinical Trials – From the standpoint of regulatory submissions
•   Remote trials – approaching strategies concurring with reality
•   Clinical investigation under regulatory circumstances
•   Where are we heading and the way forward?

Moderator
PRASHANT BODHE, Director, CliniSearch

Panellists
YASMIN SHENOY, Senior Director - Regulatory Affairs, Sanofi
RISHI JAIN, Country Medical Head, Novartis
SOURABH FULMALI, Global Medical Director, GSK
AMARNATH SUGUMARAN, Associate Director & Cluster Head Medical Affairs, Cipla
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories

AUDITS / INSPECTIONS / REGULATORY SUBMISSIONS

UTTAM C

16:10 – DISCUSSION WITH EXPERTS: Audits & Inspection - Regulatory Submissions, Information & Document Management

•   Latest trends, innovations, and best practices
•   Accelerating your regulatory submissions
•   Importance of communicating effectively with your decision-makers regarding strategy and resource requirements
•   Common pain points surrounding regulatory submissions and solutions
•   Strategic Innovation in Regulatory: Advancing Technology and Its Impact on Submissions
•   Quality audits – critical observance and current developing scenario in documentation
•   Proactive approach for Regulatory Compliance
•   Regulatory Intelligence as a strategic partner for Regulatory submissions
•   FDA – warning letters, approvals, and advancements in regulatory inspections

Moderator
VARSHA NARAYANAN, Founder-Director, Dr Varsha’s Health Solutions

Panellists
ANAND SAXENA, Director - Regulatory Affairs, Cipla
SHIRAZ KANDAWALLA, Head Regulatory, Quality and Safety - India, Ferring Pharma
PRIYESH MISTRY, Head - QA/21CFR Compliance, Intas Pharmaceuticals
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare

UTTAM C

17:00 - Closing remarks and end of conference