Global Drug Safety & PV Outsourcing Summit

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

key information

OUR STORY TO TELL THE WORLD

OUR CONFERENCE PROGRAM

This is not just another Drug safety conference. This is a conference which tells you a STORY. One personal experience followed by another, a storyline of exceptional people who happen to choose Drug Safety and Pharmacovigilance as their way to bring needed medicines and protect those who are the most vulnerable, and to improve the health of millions of people on our planet. You will hear experts talk about the current issues in this ever-evolving industry. The best practice case studies on how to integrate new, disruptive technology into the rather rigid processes of PV organization and how it evolves to stay compliant. But how to do this with the more and more restrictive budget? How to prioritize, what methodologies to use for advanced therapies? What is the next evolution step in signal detection noise clearance? Are A.I.-based tools to become our colleagues, helpmates, or our replacement? Nonetheless, each company, department, and project starts with people. But how to build a winning cross-functional team and what kind of workforce is necessary for a drug safety department of the future? What kind of skills to expect from millennials and gen-z entering the industry and why do we need veterans in the industry as well? Challenges with innovations, outsourcing, everchanging regulatory landscape, harmonization, teaching other departments on how to use RWE data, and engaging the more and more aware public. All these topics we address, are conveyed having our mission in our mind, bringing medicines and new therapeutic indications to patients, faster, safer, and more sustainably. Our visionary keynote presentations and best practice case studies will complement engaging panel discussions with different speakers to better understand Pharmacovigilance challenges and solutions from different perspectives, with unique views coming from some of the most experienced and passionate professionals. Our conference will feature numerous assisted formal and informal networking, matchmaking, and breakout sessions to create those critical business friendships that will bring fruitful cooperation and fill that missing piece in our common mission to improve drug safety and quality of life for all.

KEY TOPICS

Who will attend

Rated 5 out of 5
It's a fabulous discussion all around. People are really enthusiastic about sharing their project management insights and collaborating with others.
Derek Shannon
Director Statistical Project Management, Madrigal Pharmaceuticals
Rated 5 out of 5
We were talking about how the Why summit is where curiosity is encouraged. Where the future is bright and this is the beginning of greatness.
Rob Rowe
Account Executive, Proggio
Rated 5 out of 5
Event like this provides great opportunities to network, to meet our peers and to get new ways of working and also to gain new ideas from the network and from other companies. How they manage the current challenges they have.
Lars Jasper
CAPEX contacting manager, Bayer AG
Rated 5 out of 5
Great dialogue on key issues. Everyone shared truthful insight and did not hold back, even on negative experiences.
Sameer Thapar
Assistant Professor & Advisor

2024 Speakers

Dr. Shubhadeep Debabrata Sinha

Senior Vice President and Medical Director
Hetero

Anuja Jawale

Associate Director - RA/PV Strategic Engagements and Vendor Management
Organon

Mukesh Gori

Director - PS & PV External Engagements Novartis Pharma
Novartis

Anju Agarwal

Global Director, Global patient safety
ADVANZ PHARMA

Abhijit Surwade

Manager Global Pharmacovigilance Colgate-Palmolive

Sakshi Shrivastava Desai

Associate Director International Pharmacovigilance Global Strategy Realization
Johnson & Johnson

Dr. Devang Patel

Head of Global Pharmacovigilance
Zydus Lifesciences Limited

Vynieann Rao

Manager-DSRM (SOPs Lead and QA)
Lupin Limited

Syed Zafeeruddin

Global Pharmacovigilance Manager
Julphar

Geeta Shanbhag

Vice President - Pharmacovigilance and Medico-regulatory Affairs
Ipca laboratories Ltd

Chanbasha Shaik

Global Pharmacovigilance Head
Bridgewest Group

Chaitanya Kulkarni

General Manager Pharmacovigilance
Marksans Pharma Ltd

Gurpreet Singh

Vice President, Managing Director Integrated Safety
IQVIA

Venkata Kishore Kumar Darisi

SERM Associate Scientific Director
GSK

Vivek Gupta

Associate Director, R&D Supplier Management & Procurement
Organon

Deepak Shankarappa

Director, Pharmacovigilance
Teva Pharmaceuticals Ltd

Dr Jamal Baig

Director & MCSH- South Asia & IndoChina Region
Sanofi

Dr Arunima Sen

Associate Vice President, Product Safety and Risk Management
Viatris

Joydeep Sengupta

Global Pharmacovigilance - Site Head
Sun Pharma

Dr. Vaibhav Salvi

Director and Head – Clinical Study Unit, India and Southeast Asia, Sanofi R & D – Clinical Sciences and Operations
Sanofi

Rohan Shinde

Head of Pharmacovigilance
Crescent Pharma

Sunil Nighot

Manager, Medical Safety Performance & Compliance
Kenvue

Dr Ranjit Chavan

Global Head Pharmacovigilance
Clinexel Life Sciences

Dr. Santanu Kumar Tripathi

Principal of JIMSH & Chief Technical Advisor
JIMSH & IHS

Dr. Sharad Patel

Manager, Global Pharmacovigilance
Glenmark Pharmaceuticals

Dinesh Wagh

Manager Pharmacovigilance
Precision for Medicine

Dr Santosh Hulawale

Senior Manager, PvOI (India), SERM
Glenmark Pharmaceuticals

AGENDA

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event partners

SILVER SPONSOR

Ethicare – headquartered in Ahmedabad, India – is a leading full-spectrum PV & CTM service provider. Ethicare provides quality-driven Service to Pharmaceutical, Biotech, Medical Devices and Nutraceutical Companies across the Globe. We provide end-to-end Pharmacovigilance Services in various stages of the product cycle which includes Clinical Trial Safety Management and Post Marketing Safety Management.

Ethicare team has expertise in Medical Information Call Centre, Global Literature Management, ICSR (Adverse Event) Processing & Submissions, Aggregate Reports (DSUR, PADER, PSUR, PBRER, ASR) preparation, Signal Management, Risk Management Plan (RMP), Risk Evaluation Mitigation Strategy (REMS), Safety Management Plan (SMP), Global / Country Specific Pharmacovigilance System Master File (PSMF/PvMF), QPPV/RPPV/PvOI Service, Compliance Management, Audi/Inspection Readiness & Support, PV System Set-up for MAH. Our tailor-made and cost-effective business models help to achieve maximum client satisfaction along with meeting technical compliance.

SILVER SPONSOR

CognifAI Solutions Pvt Ltd, is a pioneering AI startup dedicated to harnessing the power of artificial intelligence to drive transformative change across various industries. While we specialize in delivering innovative AI solutions for the Pharma and Life Sciences sectors, our expertise extends across multiple domains.

Our mission is to enhance operational efficiency, optimize decision-making, and elevate customer engagement through advanced AI technologies. Some of our key solutions include:

  1. Medical Literature Monitoring for Pharmacovigilance: Cutting-edge tools for real-time tracking and analysis of medical literature to ensure drug safety and compliance.
  2. CliniOps: An advanced platform for medical document processing, including medical narration, writing, and translation.
  3. Image Validation: Precise technology for validating pharmaceutical drug labels, ensuring accuracy and regulatory adherence.

At CognifAI Solutions Pvt Ltd, we are committed to delivering customized AI solutions that address the unique challenges of each industry we serve, driving innovation and excellence across the board.

SILVER SPONSOR

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.

SILVER SPONSOR

Clinevo Technologies is an IT firm that provides regulatory compliant and user-friendly cloud-based Software Solutions for Drug Safety / Pharmacovigilance and Clinical Trials to over 200+ Pharma / CROs.

Clinevo Technologies help companies perform Pharmacovigilance in a highly efficient and cost-effective manner through their Integrated Drug Safety Platform with Database, AS2 gateway, Signal detection, Case Intake, Literature management and SDEA agreements capabilities.

Clinevo Cloud-based software / databases have been validated by several international authorities, including the USFDA, EMA, MHRA, Health Canada, DCGI, and others, and meet regulatory requirements such as HIPAA, ICH, GxP, 21 CFR Part 11, Annex 11, GDPR, and others. 

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