India Chapter
June 2025
Unity in Safety: Elevating Indian Pharmacovigilance to Global Excellence.
- Venue: Holiday Inn & Suites Dubai Science Park, an IHG Hotel, Dubai, UAE.
- IHG Hotel, Dubai Science Park, Dubai, UAE.
At Drug Safety Symposium 2024, we are at the forefront of ensuring drug safety through the rigorous practices of pharmacovigilance, regulatory compliance, and quality assurance. Our premier gathering provides a dynamic platform where attendees can explore the latest industry trends, stay updated on regulatory changes, and discover innovative solutions that drive the pharmaceutical industry forward. We are committed to excellence and facilitating meaningful discussions, knowledge sharing, and collaboration.
Book NowIn an ever-evolving pharmaceutical landscape, the importance of drug safety cannot be overstated. Each day, countless lives depend on the efficacy and safety of pharmaceutical products. Our mission is to advance the critical mission of ensuring that every drug is not only effective but also safe for consumption.
Book NowWhat sets Drug Safety Symposium 2024 apart is our unique approach. We combine insightful knowledge sharing with interactive workshops and networking opportunities, all in an atmosphere of camaraderie and fun. It's not just an event; it's an experience that empowers you to make informed decisions and contribute to the highest standards of drug safety and quality.
Book NowOur Commitment
Global Thought Leadership
Interactive Learning
Cutting-Edge Technology
Regulatory Insights
Past Speakers
President &
Chief Quality Officer,
Lupin
SCIENTIST-E in QMS & REGULATORY, AMTZ, Vizag
(Former Drug Controller of India)
Head- Global Pharmacovigilance
Vice President – Pharmacovigilance and Medico-regulatory affairs at Ipca Laboratories Ltd.
Vice President & Global Head – Pharmacovigilance, Glenmark Pharmaceuticals
Dy. QPPV (Asst GM) - Clinical Research & PV,
Serum Institute of India
Associate Vice President and Head of Global Medical Writing, Viatris
Head Global Pharmacovigilance, Zydus Lifesciences
Head-Pharmacovigilance · Emcure Pharmaceuticals
Global Head - Pharmacovigilance, Cipla
Executive Vice President - Medical Affairs
Director- Global Patient Safety & Pharmacovigilance,
Novartis
Founder Director
Rhyme Life Sciences
Multi-Country Safety Head, Sanofi
Vice President, 3Analytics
Past Event Partners
EXHIBIT PARTNERS
Techsol Life Sciences is an integrated PV business solutions provider for global pharma and medtech companies. Our unique PV PIVOT solution focuses on delivering high-quality and regulatory compliant pharmacovigilance and medical communications functional services using a powerful combination of subject matter experts, PV domain knowledge, lean business processes, cost-effective service models coupled with modern technology.
Our next-generation solution framework allows clients to leverage our purpose-built PV Ops platform to digitalize, automate and perform real-time oversight of Intake, ICSR Operations, Quality Assurance, Agreements Management, Aggregate Reporting, Literature Monitoring, PSMF Management, and significantly increase quality, compliance, and productivity of PV & MICC operations. With our Oracle Argus Safety, E2B Gateway, and Empirica Signal expertise, we are known for safety system implementation, migration, validation, integration, reporting, application support, and change management to orchestrate regulatory compliant drug safety operations.
Learn More
Our Solutions
Pharmacovigilance:
– Safety Database: Solutions for Drugs, Devices, Vaccines, and Combinational Products.
– Literature Automation: Streamlined literature management.
– ICSR Submission Automation: Effortless case report submissions.
– Smart EV Triage Automation: Intelligent event triage.
– Signal Automation: Proactive safety signal management.
– Document Management: Handling of PADER, SDEA, and reports.
Clinical Research:
– Early & Late Phase Trials: Support for clinical trial management.
– Regulatory Services:
– eCTD / CTD: Electronic and traditional submissions.
– RIMS: Regulatory Information Management Systems.
Quality:
– Quality Processes: Enhancing quality management.
– Document Management: Managing SOPs, Protocols, etc.
– Training Management: Comprehensive training solutions.
Consulting:
– Advanced Analytics: Strategic data insights.
– Digital Bots: Task automation.
– AI/ML Automations: Innovative AI and machine learning solutions.
With a global user base of 75,000+ in over 50 countries, Sarjen Systems is a trusted partner for digital transformation. Let us help you drive business efficiency with technology.
“ Vizen Life Sciences is a global leader in delivering comprehensive End-to-End Pharmacovigilance and Regulatory services. Our team of highly qualified medical professionals, including physicians and pharmacists, provides full vigilance support for a wide range of products, from generics to innovators and advanced therapies. Our services encompass medical information call centres, ICSR processing and reporting, global medical literature monitoring, aggregate report writing, risk management, signal detection, HHE reports, safety data exchange agreements, legacy data migration, and QPPV services for the EU, UK, Australia, Vietnam, Africa, and GCC countries.
What sets us apart is our ability to provide cost-effective, end-to-end PV, Regulatory, and QPPV services on a single platform, integrating enterprise-specific safety databases, MICC case-intake tools, digitized QMS, and training from Caliber Learn IQ tool. This seamless integration ensures efficient PV processes and exceptional client satisfaction.
Our pharmaceutical clients benefit from our high-quality pharmacovigilance services, delivered with a focus on compliance and customer satisfaction. We have also developed an in-house AI tool for rapid daily literature searches across therapeutic areas and fully digitized our Quality Management Systems.
At Vizen Life Sciences, we prioritize quality-driven, cost-effective solutions for global pre- and post- approval pharmacovigilance and related product safety services. With strategic locations in India and European global hubs, we offer extensive support and regulatory compliance, including GMP and GCP audits, certifications, and regulatory dossier preparations.
Contact us today to learn how we can support your global pharmacovigilance needs.”
SESSION PARTNERS
Rhyme Life Sciences Private Limited(RLS) is established in 2017 with the determination and commitment to offer the Pharmaceutical industry with the solutions which are innovative, and compliance driven thereby meeting the regulatory expectations. We committed to deliver accurate, timely and cost-effective services throughout the regulated markets. We are team comprising of experienced professional including physicians, pharmacists, life science graduates and post graduates. Team is well acquainted with the regulatory needs including but not limited to USFDA, EMA, TGA, CDSCO and others. We are assertive and confident to have ‘know how’ We are proud to highlight our expertise in handling USFDA and MHRA inspections.
Our services:
1. Literature monitoring: Literature screening, Follow up of lit. reports, screening of non-valid articles, signal report based on non-valid articles
2. Review of MLM source data, xml file(including acceptance and/or rejection)
3. Case processing: Mailbox handling, book-in/log in, triage, data entry, quality review, medical review, case lock, case submission
4. Aggregate report: PSUR(R1), PBRER (R2), PADER, India PBRER
5. RMP: EU RMP, Non EU RMP
6. Signal management: Including signal detection, signal evaluation, prioritising and drafting signal reports
7. Setting up PV system- This include PV policy, SOP preparation, resource estimate, mailbox, internal communication, formation of safety review committee
8. PSMF maintenance
9. SDEA management
10. HHE reports
11. Third party audit
12. Training to partners
13. SPC/PIL comparison
14. QPPV/local QPPV services
15. Preparation of DSUR
16. Consultation on MHRA, USFDA and other Regulatory Inspections. Rich experience in handling the inspections.
3Analytics Inc., founded in January 2020 in Silicon Valley, CA, is dedicated to enhancing drug and vaccine safety through AI and global data aggregation. The company brings together passionate experts from multiple disciplines to save lives. 3Analytics has made significant strides, partnering with JHPIEGO, a Johns Hopkins Public Health affiliate, to blend pharmacovigilance with public health. Recognized for its innovative approach, 3Analytics has been shortlisted by the WHO for Active Vaccine Safety Surveillance and Cohort Event Monitoring, highlighting its commitment to advancing global health and safety.
PRICING
INR 50000*
USD 1800*
* Pricing is applicable for Pharma Manufacturing companies only.
Partners
Why Partner at Drug Safety Symposium – India Chapter?
By partnering with us, you can position your brand at the forefront of the pharmaceutical landscape and gain invaluable exposure to a highly targeted and influential audience.
Partnering with the Drug Safety Symposium is a strategic investment, to explore sponsorship opportunities and discuss customized packages, please contact us at [email protected]
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