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2nd Global Drug Safety & PV Outsourcing Summit 2025

World’s greatest minds in drug safety, pharmacovigilance, data analysis, reporting, government policy, and innovative technology united under the Why Summits Future of Pharmacovigilance World Tour

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key information

  • Location: Fairfield by Marriott Mumbai International Airport, Samitha Industrial Estate, Plot No. 16-B, Andheri - Kurla Rd, Saki Naka, Mumbai
  • Part of the Pharmacovigilance World Tour
  • September 23-24, 2025
  • 9:00 - 17:30 Local Time
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About the event

Welcome to the 2nd Global Drug Safety & PV Outsourcing Summit 2025, a culminating conference of our World tour of Pharmacovigilance in Mumbai! After our last annual event we are thrilled to gather our vibrant community of safety professionals to explore the future of pharmacovigilance. 

Our event features inspiring keynotes, practical case studies, and engaging panel discussions, offering insights from passionate industry experts. Join our numerous networking opportunities to build crucial business relationships and keep up to date with industry developments.  

Let’s come together in Mumbai to advance our mission of delivering safer, faster, and more sustainable medicines to patients.

HERE’S WHAT YOU CAN EXPECT:  

  •  PEER-TO-PEER NETWORKING: We specialize in providing peer-2-peer level networking experience for pharma & biotech professionals.  
  •  TOP-MANAGEMENT EXPERTISE: Bringing together the industry leaders in the field to share strategic perspectives and insights that are shaping the industry.  
  • IN-DEPTH & INTERACTIVE: In contrast to loud, large-scale exhibitions, our events are setup to be discussion-driven for our participants to have meaningful conversations in a relaxed networking environment. 

KEY TOPICS

  • 2025 outlook, trends and upcoming challenges 
  • Expanding pipeline & increased demand for PV outsourcing
  • Patient-centric approaches in signal detection
  • Aligning outsourcing strategy with the overall safety function strategy
  • Ensuring data integrity and accuracy in safety reporting   
  • Intertwining global and local collaboration in expanding PV market
  • Updates on global signal detection & risk management strategies
  • Global harmonization challenges for local pharma
  • Latest Technology in PV - A.I. & M.L. Implementation

Target audience

  • Drug safety & Pharmacovigilance executives 
  • Heads of global safety programs 
  • Benefit-Risk assessment management
  • Medical affairs management
  • PV auditors 
  • RWE specialists
  • Patient safety management 
  • Compliance specialists
  • Post-market researchers 
  • Regulatory affairs directors 
  • Compliance specialists 
  • Pharma IT management 
  • Safety consultants 

Event Speakers

Chaitanya Kulkarni

General Manager - Pharmacovigilance

Marksans Pharma

Shailesh Joshi

Senior Director of ICSR

Primevigilance

Ganesh Vemula

Vigilance Process Lead

Novartis

Amit Sood

Senior Vice President, Enterprise Products

Quark

Pooja Payal Singh

Director Strategic Accounts

TransPerfect Life Sciences

Chanbasha Shaik

Head Global Pharmacovigilance

Joydeep Sengupta

Global Pharmacovigilance - Site Head

Curateq Biologics

Dr. Girijaa Kadam

Director - Global Safety Officer

Sanofi

Jamal Baig

Multi Country Safety Head

Sanofi

Dr Siva Kumar

Head of Signal and Risk Management

Amgen

event partners

GOLD PARTNER

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.

GOLD PARTNER

At Alwis Group, we’re pioneering AI-driven solutions for the healthcare and pharmaceutical industries. Our innovative tools are transforming pharmacovigilance, enhancing drug safety monitoring, and streamlining regulatory compliance. Our suite of products includes: 

* ReTrans Enterprise: AI-powered literature surveillance 

* ReTrans Extension: Browser plugin for real-time safety data analysis 

* ScoMed: Intelligent medical literature scoring * ZiNex: Advanced medical document processing 

* ZiQuel: AI-driven quality complaint management 

* ZiTrack: Smart inbound receipt management 

We’re committed to improving patient safety and operational efficiency through cutting-edge technology. Our solutions reduce costs, minimize errors, and accelerate processes, allowing healthcare professionals to focus on what matters most – patient care. 

GOLD PARTNER

Quark empowers the world’s largest pharmaceutical companies to automate the production of their highly regulated or complex documentation, so they can approve and publish it faster, and stay compliant. It enables them to accelerate regulatory approvals, release the bottlenecks around content collaboration, and get their drugs to market in record time. Quark Publishing Platform (QPP) NextGen, the cloud-based, AI-powered component content management system (CCMS) with native XML-based structured authoring using Microsoft Word, helps pharmacovigilance teams centralize and simplify the processes involved in co-authoring and approving the PV system’s critical drug safety documentation. This starts with the master file (PSMF) and traverses through all aggregated and regulatory affairs reports, including development safety update reports (DSURs), periodic adverse drug experience reports (PADERs), periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and risk management plans (RMPs).

PANEL PARTNER

TransPerfect Life Sciences offers global content solutions for the pharmaceutical, biotech, and medical device industries. With industry experts, specialists (like TMF, COA, medical writing, and marketing, among many others), certified linguists, and advanced technology, we accelerate the commercialization process for life sciences companies from lab through launch. Trust TransPerfect for precise, efficient, and cost-effective global content solutions. TransPerfect Life Sciences is a division of TransPerfect, a family of companies and solutions dedicated to being the world’s leading enabler of global communications.

Our Valued Past Partners

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Testimonials

Rated 5 out of 5
Last week, Attended “Global Drug Safety and PV Outsourcing Summit 2024, Mumbai” as a Speaker and addressed on topic “Advances in Signal Detection & Risk Management”. It was a mesmerizing experience ! Thank you Why Summits and Lubos Kusy for inviting !
Dinesh Wagh
Manager, Safety Submissions (Clinical Trials), Precision For Medicine
Rated 5 out of 5
I had the privilege of attending the Global Drug Safety and PV Outsourcing Summit on 22-23 October 2024 in Mumbai. It was an incredibly insightful event, packed with valuable discussions and forward-thinking ideas. While many topics were discussed, I found the following particularly important: Cost Center vs. Cost-Effective, Patient-Centric PV, Biosimilars and PV, Leveraging AI and LLM
Sunil Thakur
Sr. Manager - Medical Affairs and QPPV, Exeltis India
Rated 5 out of 5
Enjoyed it lot. Thanks Why Summits.
Dr. Shubhadeep D Sinha
Senior Vice President CD&MA
Rated 5 out of 5
I am truly honored to have had the opportunity to moderate such an engaging and thought-provoking panel discussion on "addressing challenges in signal detection and risk management" and "addressing inconsistencies in data reporting and leveraging technology solutions, how technology can help ? at WHY SUMMITS, GLOBAL DRUG SAFETY SUMMIT, MUMBAI
Dr. Deepak S.
MD, Director, Pharmacovigilance- Medical Scientific Unit, Teva Pharmaceuticals
Rated 5 out of 5
Just wrapped up an incredible experience at the Global Drug safety & PV Outsourcing Summit and AI tools (22 to 23-Oct-2024 in Mumbai). A huge thank you to the organizers #whysummit for their exceptional hospitality and for creating such a welcoming and engaging atmosphere. The insights shared and the connections made were invaluable. From innovative solutions to thought-provoking discussions on the future of outsourcing, this event truly exceeded my expectations.
Ismail Ahmed
Deputy Manager, Viatris
Rated 5 out of 5
I had the privilege of sharing the stage with industry experts at the recent Global Drug Safety & PV Outsourcing Summit, organized by Why Summits on the topic of ‘Challenges in Signal and Risk Management'. The event featured in-depth discussions on a range of topics, including end-to-end pharmacovigilance activities, advances in signal detection, affiliate management, evolving regulations, and more, all offering valuable insights.
Dr. Santosh Hulawale
Senior Manager- SERM & PvOI (India), Glenmark Pharmaceuticals

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