39th Pharmacovigilance India 2025
39th Pharmacovigilance India 2025
19th & 20th November, 2025
Hotel kohinoor continental, Mumbai, India
5 Reasons to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminating travel hassles while accessing high-quality content at your own pace.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
An Agenda Made For You
High quality content that addresses your biggest challenges and uncovering hidden opportunities.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Event Speakers
SOMNATH BASU
National Regulatory Authority for Drugs
MAYUR PARMAR
FDA
KHAUDEJA BANO
Amgen (USA)
RAJ K BHOGAL
Jazz Pharmaceuticals
PRASAD D
Cipla
PRATIK SHAH
Bharat Serums and Vaccines
VIPIN SETHI
Cadila
RAHUL GUPTA
USV
MILIND ANTANI
Nishith Desai Associates
GEETA SHANBHAG
Ipca Laboratories
SANTOSH TAUR
Pfizer
VAIBHAV SALVI
Sanofi
PRABHAT SINHA
Boehringer Ingelheim
RISHI JAIN
Novartis
SHIRAZ K
Ferring Pharmaceuticals
SAKSHI S D
Johnson & Johnson
MUKESH GORI
Novartis
INDU NAMBIAR
Sanofi
SOURABH F
GSK
ROHINI PANDEY
Abbott
HARSHAD MALVE
Kenvue
JYOTSNA P
Novartis
DHWANI D
Otsuka Pharmaceutical
JAMAL BAIG
Sanofi
RENUKA NEOGI
Sun Pharma
SADANAND K
Fresenius Kabi
JEROZE DALAL
GSK
MAYUR M
Alkem Laboratories
KRUNAL DALAL
GSK
RAHUL SOMANI
Alkem Laboratories
APARNA P
Wockhardt
VYNIE ANN RAO
Glenmark
SUCHITA MORE
MSD
CHITRA BARGAJE
Lupin
GIRISH SANE
Bristol Laboratories
KAVITA LAMROR
Maxis Clinical Sciences
SHRADDHA B
Sandoz
KHOKAN D
Wockhardt
BIJENDER M
Alkem Laboratories
RASHMI HEGDE
GSK (Former)
JOYDEEP S
Sun Pharmaceuticals
MARTINA GOMES
Bayer Pharmaceuticals
ANUJA JAWALE
Organon
MEERA NAGARIA
Johnson & Johnson
SOUVIK C
Novartis
MUGDHA SHAH
Sanofi
JYOTI KASHID
Lundbeck
VANSHIKA B
Novartis
KUSHAL SARDA
Shalina Healthcare
CHAITANYA K
Marksans Pharma
VISHWAS SOVANI
Pharmawisdom
Event Schedule
Meet to learn and network with your conference colleagues.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Welcome address and Opening Remarks
09:30 – Keynote Address - Safety Reporting - Aspiration of a global integrated ecosystem.
SAFETY
Speaker
KHAUDEJA BANO
Vice President Combination Product Quality
Amgen (USA)
10:00 – Keynote Panel Discussion: Pharmacovigilance for Tomorrow: Navigating Challenges and Uncovering Opportunities
CHALLENGES & OPPORTUNITIES
- Tackle data overload and integration barriers in effective PV implementation.
- Examine the gaps between pre-marketing potential and post-marketing reality.
- Question if accelerated drug approvals compromise patient safety.
- Explore complexities in adopting AI and automation within PV systems.
- Discuss challenges in global literature monitoring for drug safety.
- Identify misconceptions, misuse, and underrecognized factors in ADR causation.
Moderator
VIPIN SETHI
VP International Business, Head Global PV Function
Cadila
Panellists
RISHI JAIN
Country Medical Head
Novartis
INDU NAMBIAR
Pharmacovigilance Lead & Country Safety Head
Sanofi
SAKSHI SHRIVASTAVA DESAI
Associate Director International PV Strategy Realization
Johnson & Johnson
KRUNAL DALAL
Head Medical Affairs
GSK
GIRISH SANE
GM & Head Pharmacovigilance
Bristol Laboratories
CHAITANYA KULKARNI
GM Pharmacovigilance
Marksans Pharma
11:00 – Morning Coffee/Tea & Discussion
11:30 – Panel Discussion: Patient-Centric Pharmacovigilance: Amplifying the Patient Voice in Drug Safety
PATIENT SAFETY
- Address unconscious bias in pharmacovigilance and explore mitigation strategies.
- Trace the shift from reactive to proactive patient safety models.
- Examine the role of patient input in signal detection and ADR prevention.
- Highlight the importance of protecting vulnerable patient groups.
- Discuss challenges in patient engagement, including tech access and language barriers.
- Emphasize the value of patient-reported outcomes in improving safety reporting and empowerment.
- Explore how public awareness enhances pharmacovigilance systems and data quality.
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
VAIBHAV SALVI
Director & Head – Clinical Study Unit, India & South East Asia
Sanofi
SOURABH FULMALI
Global Medical Director – Respiratory
GSK
RENUKA NEOGI
Head & Deputy GM – Global Clinical Quality Management
Sun Pharma
JAMAL BAIG
Multi Country Safety Head
Sanofi
SHRADDHA BHANGE
Senior Medical Safety Lead
Sandoz
12:20 - Topic TBC
For sponsorship opportunities please contact info@virtueinsight.com
12:50 – Networking luncheon
13:50 – Panel Discussion - The “Next Generation” risk management strategies
RISK MANAGEMENT
- Implementation and maintenance of RMP’s – Overcoming its challenges
- Potential analyzing of safety and risk signals in PV
- Strategies to minimize the risk measures – what are the new developments?
- Benefit/Risk ratio: the common Denominator
- Stakeholders in RMP – Communications must be improved
- Implementing a Risk-Based Monitoring Solution: Understanding the basics of a sustainable model
- Discussing about the strategies that support the PV from beginning to end
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
PRASAD DESHMUKH
Vice President & Head Pharmacovigilance
Cipla
JEROZE DALAL
Head of Clinical Operations, Governance & Risk Management
GSK
CHITRA BARGAJE
Sr.GM, Global Head PV, Drug Safety & Risk Management
Lupin
14:40 - Regulations on Pharmacovigilance in India
REGULATORY
- Regulations overview
- Practical scenario/ scope of improvement
- Interface of PV with regulatory
- Best practices across the global on PV practices
Speaker
MARTINA GOMES
Head, Reg Affairs – CH, South Asia
Bayer
15:10 – Afternoon Tea/Coffee
15:40 – Validation and Regulatory Compliance of Artificial Intelligence/Machine Learning enabled PV Systems
- Regulatory requirement of validation of AI-enabled and automated tools for PV.
- Computerized System Validation (CSV) vs Computer Software Assurance (CSA).
- Risk detection, assessment and mitigation of AI Systems
- AI system life cycle management —from pilot to production —innovation with compliance
- Regulatory Inspections of computerized systems in PV
Speaker
SOUVIK CHATTERJEE
Senior Global Auditor
Novartis
16:10 – Panel Discussion: Outsourcing in Pharmacovigilance: Evolving Models, Strategic Partnerships & Global Impact
OUTSOURCING
- Explore outsourcing as a strategic tool to access expertise and scale operations.
- Evaluate the pros and cons of outsourcing pharmacovigilance activities.
- Understand key concerns around training, infrastructure, and partner readiness.
- Examine cost-efficiency and budget optimization through outsourced PV systems.
- Identify best practices for building strong, effective PV partnerships.
- Learn from successful collaborations that have enhanced global drug safety.
- Respond to rising case volumes with scalable, tech-enabled PV outsourcing models.
- Fostering quality culture in vendor environments
Moderator
Panellists
MUKESH GORI
Associate Director -ESP Management CMO & PS
Novartis
RAHUL SOMANI
Head- Global Pharmacovigilance
Alkem Laboratories
ROHINI PANDEY
Regional PV Head- SEA
Abbott
VYNIE ANN RAO
Senior Manager
Glenmark
JYOTI KASHID
Manager, Global Patient Safety Operations
Lundbeck (Singapore)
VANSHIKA BRIJWANI
Manager Country Development Quality (CDQ)
Novartis
17:00 - Closing remarks and end of conference
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Welcome address and Opening Remarks
09:30 – Keynote Address - Safety Reporting - Aspiration of a global integrated ecosystem.
SAFETY
Speaker
KHAUDEJA BANO
Vice President Combination Product Quality
Amgen (USA)
10:00 – Keynote Panel Discussion: Pharmacovigilance for Tomorrow: Navigating Challenges and Uncovering Opportunities
CHALLENGES & OPPORTUNITIES
- Tackle data overload and integration barriers in effective PV implementation.
- Examine the gaps between pre-marketing potential and post-marketing reality.
- Question if accelerated drug approvals compromise patient safety.
- Explore complexities in adopting AI and automation within PV systems.
- Discuss challenges in global literature monitoring for drug safety.
- Identify misconceptions, misuse, and underrecognized factors in ADR causation.
Moderator
VIPIN SETHI
VP International Business, Head Global PV Function
Cadila
Panellists
RISHI JAIN
Country Medical Head
Novartis
INDU NAMBIAR
Pharmacovigilance Lead & Country Safety Head
Sanofi
SAKSHI SHRIVASTAVA DESAI
Associate Director International PV Strategy Realization
Johnson & Johnson
KRUNAL DALAL
Head Medical Affairs
GSK
GIRISH SANE
GM & Head Pharmacovigilance
Bristol Laboratories
CHAITANYA KULKARNI
GM Pharmacovigilance
Marksans Pharma
11:00 – Morning Coffee/Tea & Discussion
11:30 – Panel Discussion: Patient-Centric Pharmacovigilance: Amplifying the Patient Voice in Drug Safety
PATIENT SAFETY
- Address unconscious bias in pharmacovigilance and explore mitigation strategies.
- Trace the shift from reactive to proactive patient safety models.
- Examine the role of patient input in signal detection and ADR prevention.
- Highlight the importance of protecting vulnerable patient groups.
- Discuss challenges in patient engagement, including tech access and language barriers.
- Emphasize the value of patient-reported outcomes in improving safety reporting and empowerment.
- Explore how public awareness enhances pharmacovigilance systems and data quality.
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
VAIBHAV SALVI
Director & Head – Clinical Study Unit, India & South East Asia
Sanofi
SOURABH FULMALI
Global Medical Director – Respiratory
GSK
RENUKA NEOGI
Head & Deputy GM – Global Clinical Quality Management
Sun Pharma
JAMAL BAIG
Multi Country Safety Head
Sanofi
SHRADDHA BHANGE
Senior Medical Safety Lead
Sandoz
12:20 - Topic TBC
For sponsorship opportunities please contact info@virtueinsight.com
12:50 – Networking luncheon
13:50 – Panel Discussion - The “Next Generation” risk management strategies
RISK MANAGEMENT
- Implementation and maintenance of RMP’s – Overcoming its challenges
- Potential analyzing of safety and risk signals in PV
- Strategies to minimize the risk measures – what are the new developments?
- Benefit/Risk ratio: the common Denominator
- Stakeholders in RMP – Communications must be improved
- Implementing a Risk-Based Monitoring Solution: Understanding the basics of a sustainable model
- Discussing about the strategies that support the PV from beginning to end
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
PRASAD DESHMUKH
Vice President & Head Pharmacovigilance
Cipla
JEROZE DALAL
Head of Clinical Operations, Governance & Risk Management
GSK
CHITRA BARGAJE
Sr.GM, Global Head PV, Drug Safety & Risk Management
Lupin
14:40 - Regulations on Pharmacovigilance in India
REGULATORY
- Regulations overview
- Practical scenario/ scope of improvement
- Interface of PV with regulatory
- Best practices across the global on PV practices
Speaker
MARTINA GOMES
Head, Reg Affairs – CH, South Asia
Bayer
15:10 – Afternoon Tea/Coffee
15:40 – Validation and Regulatory Compliance of Artificial Intelligence/Machine Learning enabled PV Systems
- Regulatory requirement of validation of AI-enabled and automated tools for PV.
- Computerized System Validation (CSV) vs Computer Software Assurance (CSA).
- Risk detection, assessment and mitigation of AI Systems
- AI system life cycle management —from pilot to production —innovation with compliance
- Regulatory Inspections of computerized systems in PV
Speaker
SOUVIK CHATTERJEE
Senior Global Auditor
Novartis
16:10 – Panel Discussion: Outsourcing in Pharmacovigilance: Evolving Models, Strategic Partnerships & Global Impact
OUTSOURCING
- Explore outsourcing as a strategic tool to access expertise and scale operations.
- Evaluate the pros and cons of outsourcing pharmacovigilance activities.
- Understand key concerns around training, infrastructure, and partner readiness.
- Examine cost-efficiency and budget optimization through outsourced PV systems.
- Identify best practices for building strong, effective PV partnerships.
- Learn from successful collaborations that have enhanced global drug safety.
- Respond to rising case volumes with scalable, tech-enabled PV outsourcing models.
- Fostering quality culture in vendor environments
Moderator
Panellists
MUKESH GORI
Associate Director -ESP Management CMO & PS
Novartis
RAHUL SOMANI
Head- Global Pharmacovigilance
Alkem Laboratories
ROHINI PANDEY
Regional PV Head- SEA
Abbott
VYNIE ANN RAO
Senior Manager
Glenmark
JYOTI KASHID
Manager, Global Patient Safety Operations
Lundbeck (Singapore)
VANSHIKA BRIJWANI
Manager Country Development Quality (CDQ)
Novartis
17:00 - Closing remarks and end of conference
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 - Materiovigilance in India: Strengthening Safety Structures for Medical Devices
MATERIOVIGILANCE
- Distinct vigilance systems are needed for medicines and medical devices.
- Device safety and performance are critical to protecting patient health.
Stakeholders must actively support post-market and market surveillance. - Underreporting of adverse events limits effective risk evaluation.
- Continuous safety monitoring ensures regulatory compliance and trust.
- India’s materiovigilance framework must evolve with global best practices.
Speaker
APARNA PRABHUNE
Assistant General Manager – Regulatory Affairs
Wockhardt
10:00 – Panel Discussion - The Digital Future of Pharmacovigilance: Innovation, Intelligence & Integration
TECHNOLOGY
- Leverage big data and predictive modelling for early detection of safety signals.
- Utilize real-world data to enhance drug safety and operational excellence.
- Explore the growing role and impact of AI in pharmacovigilance.
- Integrate diverse data sources to strengthen data-driven safety decisions.
- Examine how digital tools are transforming communication across PV stakeholders.
- Assess the role of social media and digital platforms in adverse event reporting.
- Balance tech innovation with the need to uphold drug safety standards.
- Discuss innovation through drug repurposing and agile PV systems.
Moderator
RASHMI HEGDE
Former Executive Vice President Medical Affairs
GSK
Panellists
BIJENDER MISHRA
Sr. GM & CISO
Alkem Laboratories
SUCHITA MORE
Associate Director Medical Affairs
MSD
DHWANI DHOLAKIA
Division Head – Information Technology
Otsuka Pharmaceutical
MEERA NAGARIA
Senior Data Scientist
Johnson & Johnson (Boston, USA)
10:50 – Morning Coffee/Tea & Discussion
11:20 – Panel Discussion- Managing Pharmacovigilance Audits & Inspections
AUDITS & INSPECTIONS
- Staying ahead in the race – Current trends for and future guidelines
- How to prepare and what to expect?
- Remote audits and inspections – Logistical issues
- PV Inspection readiness: Keeping on the right side of inspectors
- Methodologies, scope and oversight
- Boldly shaping the future
- What has this pandemic thought us towards audits and inspections?
Moderator
RAJ K BHOGAL
Sr. Director, R&D Business Strategy & Operations
Jazz Pharmaceuticals (UK)
Panellists
JYOTSNA PATWARDHAN
Cluster Head Clinical/PV QA at Africa, Middle East, Turkey &
India
Novartis
JOYDEEP SENGUPTA
Global Pharmacovigilance – Site Head
Sun Pharmaceuticals
MUGDHA SHAH
PV Audit and Inspection Readiness Manager
Sanofi
12:10 - Topic TBC
For sponsorship opportunities please contact info@virtueinsight.com
12:40 – Networking luncheon
13:50 – Panel Discussion - Why RWD and RWE is crucial for Pharmacovigilance
RWD / RWE
- Importance of real-world data for answering questions
- Benefits and challenges of evidence derived from real world sources
- Real World Evidence: How Does its Use challenge quality and compliance programs?
Obtaining patient-centric using RWE - Implications of RWE for Quality and Compliance
- What are complications that will rise by inserting new data source? Breakup in data?
- Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
Moderator
KAVITA LAMROR
Partner, RWE & Digital Transformation
Maxis Clinical Sciences
Panellists
PRATIK SHAH
Vice President Medical Affairs
Bharat Serums and Vaccines
SANTOSH TAUR
Director Medical Affairs, Ex-Chair, RWE Council, ISCR
Pfizer
HARSHAD MALVE
Medical Head – Self-Care & Operations
Kenvue
MAYUR MAYBHATE
Head Medical Affairs
Alkem Laboratories
KUSHAL SARDA
GM & Head – Medical Affairs, Clinical Research & PV
Shalina Healthcare
14:40 – Pharmacovigilance in South Asia: A Regional Perspective on Drug Safety Challenge
Overcoming underreporting of ADRs due to cultural and socioeconomic factors. Developing community-centric approaches to improve PV participation.
Speaker
ANUJA JAWALE
Associate Director – RA/PV Strategic Engagements &
Vendor Management, Organon
15:10 – Afternoon Tea/ Coffee & Networking
15:40 - Panel Discussion – Regulatory: Current Scenario & Key Reforms Needed to Ensure Safer Drugs for Patients
REGULATORY
As the global pharmacovigilance landscape continues to evolve, the regulatory environment remains both a guiding framework and a formidable challenge. This session will explore the current regulatory scenario and assess what reforms are needed to ensure patient safety without stifling innovation.
- Navigating global PV compliance in an increasingly complex regulatory environment
- Adapting to intensified safety regulations and aligning with international expectations
- Leveraging real-world data and evidence to support regulatory decisions
- Addressing challenges in PV and MV reporting and submission frameworks
- Building inspection-ready systems to manage evolving and diverse regulatory demands
- Balancing global regulatory convergence with local adaptability and reduced industry burden
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
SOMNATH BASU
Team Leader Reviewers of Drugs
National Regulatory Authority for Drugs (NRA India)
MAYUR PARMAR
Drugs Inspector (Deputy Collector, Gujarat Government)
FDA
RAHUL GUPTA
Vice President, Regulatory Affairs
USV
GEETA SHANBHAG
VP – PV & Medico-Regulatory Affairs
Ipca Laboratories
PRABHAT SINHA
Director Government & Public Affairs
Boehringer Ingelheim
SHIRAZ KANDAWALLA
Associate Director
Ferring Pharmaceuticals
SADANAND KULKARNI
Head- Medical, Regulatory, Vigilance & Quality
Fresenius Kabi
KHOKAN DEBNATH
Sr. GM – Regulatory Affairs, Clinical Operations, PV & QA
Wockhardt
16:50 – Lucky Draw / Closing remarks & end of conference
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 - Materiovigilance in India: Strengthening Safety Structures for Medical Devices
MATERIOVIGILANCE
- Distinct vigilance systems are needed for medicines and medical devices.
- Device safety and performance are critical to protecting patient health.
Stakeholders must actively support post-market and market surveillance. - Underreporting of adverse events limits effective risk evaluation.
- Continuous safety monitoring ensures regulatory compliance and trust.
- India’s materiovigilance framework must evolve with global best practices.
Speaker
APARNA PRABHUNE
Assistant General Manager – Regulatory Affairs
Wockhardt
10:00 – Panel Discussion - The Digital Future of Pharmacovigilance: Innovation, Intelligence & Integration
TECHNOLOGY
- Leverage big data and predictive modelling for early detection of safety signals.
- Utilize real-world data to enhance drug safety and operational excellence.
- Explore the growing role and impact of AI in pharmacovigilance.
- Integrate diverse data sources to strengthen data-driven safety decisions.
- Examine how digital tools are transforming communication across PV stakeholders.
- Assess the role of social media and digital platforms in adverse event reporting.
- Balance tech innovation with the need to uphold drug safety standards.
- Discuss innovation through drug repurposing and agile PV systems.
Moderator
RASHMI HEGDE
Former Executive Vice President Medical Affairs
GSK
Panellists
BIJENDER MISHRA
Sr. GM & CISO
Alkem Laboratories
SUCHITA MORE
Associate Director Medical Affairs
MSD
DHWANI DHOLAKIA
Division Head – Information Technology
Otsuka Pharmaceutical
MEERA NAGARIA
Senior Data Scientist
Johnson & Johnson (Boston, USA)
10:50 – Morning Coffee/Tea & Discussion
11:20 – Panel Discussion- Managing Pharmacovigilance Audits & Inspections
AUDITS & INSPECTIONS
- Staying ahead in the race – Current trends for and future guidelines
- How to prepare and what to expect?
- Remote audits and inspections – Logistical issues
- PV Inspection readiness: Keeping on the right side of inspectors
- Methodologies, scope and oversight
- Boldly shaping the future
- What has this pandemic thought us towards audits and inspections?
Moderator
RAJ K BHOGAL
Sr. Director, R&D Business Strategy & Operations
Jazz Pharmaceuticals (UK)
Panellists
JYOTSNA PATWARDHAN
Cluster Head Clinical/PV QA at Africa, Middle East, Turkey &
India
Novartis
JOYDEEP SENGUPTA
Global Pharmacovigilance – Site Head
Sun Pharmaceuticals
MUGDHA SHAH
PV Audit and Inspection Readiness Manager
Sanofi
12:10 - Topic TBC
For sponsorship opportunities please contact info@virtueinsight.com
12:40 – Networking luncheon
13:50 – Panel Discussion - Why RWD and RWE is crucial for Pharmacovigilance
RWD / RWE
- Importance of real-world data for answering questions
- Benefits and challenges of evidence derived from real world sources
- Real World Evidence: How Does its Use challenge quality and compliance programs?
Obtaining patient-centric using RWE - Implications of RWE for Quality and Compliance
- What are complications that will rise by inserting new data source? Breakup in data?
- Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
Moderator
KAVITA LAMROR
Partner, RWE & Digital Transformation
Maxis Clinical Sciences
Panellists
PRATIK SHAH
Vice President Medical Affairs
Bharat Serums and Vaccines
SANTOSH TAUR
Director Medical Affairs, Ex-Chair, RWE Council, ISCR
Pfizer
HARSHAD MALVE
Medical Head – Self-Care & Operations
Kenvue
MAYUR MAYBHATE
Head Medical Affairs
Alkem Laboratories
KUSHAL SARDA
GM & Head – Medical Affairs, Clinical Research & PV
Shalina Healthcare
14:40 – Pharmacovigilance in South Asia: A Regional Perspective on Drug Safety Challenge
Overcoming underreporting of ADRs due to cultural and socioeconomic factors. Developing community-centric approaches to improve PV participation.
Speaker
ANUJA JAWALE
Associate Director – RA/PV Strategic Engagements &
Vendor Management, Organon
15:10 – Afternoon Tea/ Coffee & Networking
15:40 - Panel Discussion – Regulatory: Current Scenario & Key Reforms Needed to Ensure Safer Drugs for Patients
REGULATORY
As the global pharmacovigilance landscape continues to evolve, the regulatory environment remains both a guiding framework and a formidable challenge. This session will explore the current regulatory scenario and assess what reforms are needed to ensure patient safety without stifling innovation.
- Navigating global PV compliance in an increasingly complex regulatory environment
- Adapting to intensified safety regulations and aligning with international expectations
- Leveraging real-world data and evidence to support regulatory decisions
- Addressing challenges in PV and MV reporting and submission frameworks
- Building inspection-ready systems to manage evolving and diverse regulatory demands
- Balancing global regulatory convergence with local adaptability and reduced industry burden
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
SOMNATH BASU
Team Leader Reviewers of Drugs
National Regulatory Authority for Drugs (NRA India)
MAYUR PARMAR
Drugs Inspector (Deputy Collector, Gujarat Government)
FDA
RAHUL GUPTA
Vice President, Regulatory Affairs
USV
GEETA SHANBHAG
VP – PV & Medico-Regulatory Affairs
Ipca Laboratories
PRABHAT SINHA
Director Government & Public Affairs
Boehringer Ingelheim
SHIRAZ KANDAWALLA
Associate Director
Ferring Pharmaceuticals
SADANAND KULKARNI
Head- Medical, Regulatory, Vigilance & Quality
Fresenius Kabi
KHOKAN DEBNATH
Sr. GM – Regulatory Affairs, Clinical Operations, PV & QA
Wockhardt
16:50 – Lucky Draw / Closing remarks & end of conference
Event Testimonials
A huge thanks to all our sponsors, attendees and partners!
Pricing Details
Exclusive Offer — 3 Delegates for the Price of 2!
(For the first 50 bookings only)
SUPER EARLY BIRD PRICE — INR 16,000 + GST (18%) PER DELEGATE (Until 26th September 2025)
STANDARD PRICE — INR 21,000 + GST (18%) PER DELEGATE
You can simply email or call and book your conference delegate seats on:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
CONFERENCE SPONSOR & EXHIBITION STALL
Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
Venue details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue –
Kohinoor Continental Hotel, Mumbai, India
Andheri Kurla Road, Andheri ( E )
Mumbai 400059 – India
91 22 66919000 / 91 22 28209999
Venue
kohinoor continental Hotel,Mumbai, India
Andheri Kurla Road, Andheri ( E )
Mumbai 400059 – India
91 22 66919000 / 91 22 28209999
