Bringing over 21 years of experience across pharmacovigilance, clinical research, and medical practice, Dr. Neha Vala is a trained medical professional with strong grounding in clinical pharmacology, GCP, and global PV guidelines, she has end-to-end expertise in risk management planning, signal management, and benefit–risk evaluation. Dr. Vala has successfully established and scaled pharmacovigilance functions for multiple organisations and has led numerous regulatory inspections, including USFDA, MHRA, EU authorities, Health Canada, and DCGI. She is also an active speaker at national and international pharmacovigilance forums.

I have been with Alkem Laboratories Ltd, Mumbai, for the past 13 years in various roles and am currently serving as the Head of Global Pharmacovigilance.

With 25 years of experience spanning both academic and industrial roles, I have played a key role in establishing an in-house Pharmacovigilance department that adheres to stringent regulatory standards and processes. This has supported our global pharmacovigilance operations through the development and implementation of comprehensive safety monitoring systems, risk management plans, and regulatory compliance strategies.

In the past five years, I have successfully led my team through three major regulatory inspections for Pharmacovigilance by the USFDA, TGA-Australia, and MoH-Kazakhstan. These inspections required meticulous preparation and a deep understanding of regulatory requirements, affirming the robustness and effectiveness of our pharmacovigilance practice

Rajendra Kasi is a healthcare professional with more than 2 decades of experience in clinical and drug safety arenas. He is the Vice-president and Global Head of Pharmacovigilance at Glenmark Pharmaceuticals Ltd. Before joining Glenmark, he worked with reputed pharmaceutical companies like Zydus Cadila and Mylan Laboratories, etc. He was pivotal in establishing Pharmacovigilance units from scratch to hatch level for major pharmaceutical players in India. He believes quality consciousness, keeping oneself up-to-date with the latest happenings in the industry, and embracing and adopting new technologies in the domain are the key factors to ensure regulatory compliance.

Dr. Patel bringing over 18 years of experience in drug safety and pharmacovigilance across pharmaceutical organizations and global service businesses. He has extensive expertise in managing end-to-end PV operations, regulatory compliance, and safety system oversight across diverse markets.

Devang has successfully led and managed multiple regulatory inspections by global health authorities, demonstrating strong capabilities in audit readiness and compliance excellence. His experience across both sponsor and service environments provides him with a well-rounded perspective on operational challenges, governance, and scalable pharmacovigilance practices.

Dr. Abhay Chimankar is a globally recognized physician and pharmacovigilance leader with over 20 years of extensive experience in drug safety, pharmacovigilance, medical writing, clinical trials, BA/BE monitoring, and auditing. He brings deep expertise in the practical implementation of global regulatory guidelines, particularly the EU GVP Modules.

Known for his strategic leadership and operational excellence, Dr. Chimankar has successfully streamlined pharmacovigilance operations and delivered significant business value through efficient planning, execution, and compliance-focused systems. He is widely respected as a pharmacovigilance auditor with substantial experience handling USFDA and MHRA inspections.

During the pandemic, he conducted one of the highest numbers of pharmacovigilance audits, further strengthening his reputation as a trusted industry expert. He is also among the few third-party auditors to directly interact with Health Authorities.

A sought-after national and international speaker, panelist, and moderator, Dr. Chimankar regularly contributes to leading pharmacovigilance conferences and industry forums. Today, he is regarded as one of India’s top pharmacovigilance consultants, known for his practical insights, regulatory expertise, and commitment to advancing drug safety standards globally.

Dr. Ahmed Hegazy is a seasoned physician and pharmaceutical medicine expert with over 27 years of extensive experience across sales, medical affairs, marketing, training, and pharmacovigilance in the pharmaceutical industry. He holds a Master’s degree in Pharmaceutical Medicine with First Class Honours for his thesis on Adverse Drug Reactions in the Middle East—recognized with distinction, presented at ISoP 2017, and published in Drug Safety.

His academic journey is enriched with certifications from prestigious institutions including George Washington University (Neurology), Columbia University (Immunology and Transplantation), the Royal College of Physicians (GCP & Clinical Research), Uppsala Monitoring Centre (Pharmacovigilance), and more. He also holds a Mini MBA, and diplomas in Medical Quality and Hospital Management. Additionally, he is an ISO 9001:2015 Lead Auditor (IRCA-accredited) and a Lean Six Sigma Green Belt holder.

Dr. Hegazy served as Head of Global Patient Safety at Merck for seven years, overseeing PV operations across 82 countries with a team across eight nations. His Medical Affairs leadership spans 12+ years across various therapeutic areas, including neurology, oncology, endocrinology, immunology, and infectious diseases.

He is currently the Founder of Pvigilant Health, based in Dubai, and operates as an Executive Consultant in Medical Affairs and Pharmacovigilance for local and global firms. A respected thought leader, he regularly chairs, moderates, and speaks at conferences and trains regulatory bodies, academic institutions, and industry professionals worldwide.