14th Edition Global Pharma Regulatory Summit

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With over a decade at Biocon Limited, my journey has been dedicated to mastering the nuances of API regulatory sciences, ensuring compliance and spearheading strategic initiatives in generic product regulations. Our team's collaborative efforts have been pivotal in the vertical integration and B2B customer qualification, contributing significantly to the registration, approval, and commercialization processes.

Leveraging a robust background in GLP, technology transfer, and regulatory affairs, I've cultivated a deep understanding of the product lifecycle from development to market. My leadership has furthered cost improvement plans and forged strong alliances with R&D, manufacturing, and quality teams, ensuring excellence in all facets of regulatory science.

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Ahmedabad Regional Office

Professional Engagement at NABL

• Joint Director, based at Ahmedabad Regional Office
• Overlooking the regional outreach activities in the western region and arranging/organizing awareness programs on NABL Accreditation and its benefits, with various business organizations, government organizations, academic institutions, chamber of commerce, professional institutions etc.
• Qualified Assessor for ISO 17025 (Testing and Calibration), ISO 15189 (Medical) , ISO 17034 (RMP) , and ISO 17043 (PT Providers).

Professional Experience:

• Rich experience of 20 years in the field with prior experience as a Microbiologist in Quality Control and Quality Assurance Department at Cipla Ltd and accredited food laboratories
• Conducted 35+ audits and made 100+ presentations at conferences and training programs. 
• Represented NABL at over 20 national and international forums. 
• Coordinated 61 training programs at the national and international level.

Professional Qualifications:

• PhD in Microbial Technology from Amity University
• M.Sc. in Microbiology from Mumbai University. 
• MBA, PG Diploma in Food Safety and Quality Management (PGDFSQM), 
• Professional Diploma in Quality Management (PDQM) 
• PG Diploma in Bioinformatics (PGDB). 
   

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• MBBS (GSMC& KEMH, Mumbai, India 1991-1997) 
• MD (Pharmacology, TNMC& BYLNairH, Mumbai, India, 1997- 2000) 
• Dip. Diabetes (Apollo Hospitals, India, 2015-16), 
• PG Dip Infectious Diseases (UNSW, Australia), Fellowship in Diabetes (Royal Liverpool Academy, UK, 2018-2019),
• FCGP (Fellow college of General Practitioners (Indian Medical association, 2019)
• FRSPH (Fellowship of Royal Society of Public Health, London, UK, 2023), 
• FIPS (Fellow of Indian Pharmacological Society), 2023
• Ph.D (Public Health, CCU, 2019- 2022)
• Executive Program in Business Management (IIM – Calcutta, 2014-2015)
• MBA (Hospital Healthcare Management), BITS, PILANI, India, 2020-2022)
• FSASS(Fellow Scholars Academic & Scientific Society, 2023)

Senior pharmaceutical physician & medical pharmacologist, with > 25 years’ experience in Product Development, Project management, Preclinical Studies,, Clinical Trials, Regulatory, Pharmacovigilance & medical affairs.

Pharmaceutical Industry Experience- 25 years
 

• 2011- till date -  Hetero group (Hetero Labs, Hetero Drugs, Camber, Biopharma, Amarox, Annora) - Senior Vice - President & Medical Director Heading - Global operations of Clinical Trials, Pharmacovigilance, Medical Affairs (New Drugs/Biologics/ Discovery) . 
• 2001-2011- Previously led clinical trial and pharmacovigilance activities  at leading pharmaceutical organizations in similar roles including Dr. Reddy’s Laboratories (2003-2007), Vimta Labs(2009-2011), Indigene Alquest LLC.(2008-09) , Accenture ,  Glenmark,, Organon,  Khandelwal Laboratories.
• 1997-2001 - BYL Nair Hospital & TN Medical College (Medical Officer- Department of Pharmacology & Clinical Pharmacology & PV officer at National pharmacovigilance centre) . 

Pharmaceutical product development experience- 

• New chemical entities (HRF10071{HIV), 2-DG(Oncology}, DRF-2593{Diabetes}); NDDS (Long acting, sustained release drugs various TAs, Nail penetration antifungal, combination product, modified salts {antihypertensives, anticholesterolemic}), Biologics {13 biosimilars- Rituximab, Bevacizumab, Trastuzumab, Trastuzumab-Emtasnsine, Adalimumab, Denosumab, Darbepoetin alfa, Tenecteplase, Pembrolizumab, Tocilizumab, Filgrastim, Peg-filgrastim, Nivolimumab, Sputnik vaccine), Generics (150+). 

Project management -   Ideation, product development, tracking Preclinical studies, clinical trials, postmarketing studies. 

Preclinical Studies- Invitros, Pharmacology (pk &pd), Toxicology ( 300+ Acute, subchronic, long-term, mutagenicity & teratiogenicity, Rodent & Dog.   PDE reports- 10000+ (Supports cleaning & validation)

Clinical Trials/Research Experience – 

• a. BA/BE studies, Pk in patients, DDI, Clinical Endpoint- 500+ 
• b. Phase-3, Postauthorisation efficacy (phase-4) clinical trials, PMS, Investigator initiated studies (IIS), RWE studies-100+,  
• New Chemical/ Molecular Entities (NCEs/NMEs) in HIV, Diabetes & Cancer- Early phase phase-1, phase 2 studies. 
• Biosimilars in Cancer, Autoimmune diseases, Insulins, Hormones & Vaccines(Rituximab, Bevacizumab, Adalimumab, Trastuzumab, Trastuzumab Emtansine, Tocilizumab, Tenecteplase, Denosumab, Pembrolizumab, Erythropoietin analogues , Sputnik vaccine, Insulins, Recombinant Hormones)- Phase-1 & Phase-3 studies – Domestic and Global Clinical Trials. India, Russia, South America, Indonesia, Philippines, Australia.
• Multiple new Generics in various diseases including COVID-19 (Molnupiravir, Remdesivir, Paxlovid generic), HIV, Hepatitis - C(Sofosbuvir & combinations), Cardiology, Diabetology, oncology, gastroenterology, urology, haematology, orthopedics & rheumatology diseases - Phase-1, 3  & 4.
• 16 global meetings (USFDA, Mexico, Argentina, Turkey, Iran, Indonesia, Malaysia, Vietnam, Kenya, Zambia, South Africa, Kazakhstan, Russia, Moldova),

Pharmacovigilance Experience- 

• Established, led global pharmacovigilance/ medical safety at Hetero (Argus-safetysince 2011), at Dr. Reddy’s (Aris-g, 2003-07), Accenture (Clintrace, Abbott2008-09), Vimta Labs (2009-11) & BYL Nair Hospital& TN Medical College (PV officer at National pharmacovigilance centre; 1997-2001) . 
• Successfully faced approx. >100 regulatory inspections- USFDA, Europe, Mexico, Columbia, Indonesia, Malaysia, Canada, Kazakhstan,  South Africa   
• Academic - Adjunct faculty-Pharmacology at Kasturba Medical College (KMC), Manipal and at Indira Gandhi Institute of Medical Sciences ( IGIMS), Patna.
• PUBLICATIONS - Has 36 medical journal publications (original articles) in peer reviewed medical journals Authored two books ({AI in healthcare & Taste of Pharmacology][Available Amazon]) & 1 book chapter in a medical textbook taught in MBBS (Antihypertensives in Textbook of Pharmacology).

Awards

•  Bharat Gaurav Puraskar (KTK Foundation, (May 2024); 
•  Fellowship Indian Pharmacological Society (IPS, 2023); 
•  Lifetime achievement award (WEECE awards 2023),
•  India’s 10 most influential healthcare leaders (Tradeflock magazine May 2024

Kumar Gaurav is a seasoned leader with over 22 years of experience in the vaccines and biologics industry, driving innovation, regulatory excellence, and global market expansion. His expertise spans product development, technology transfer, and regulatory strategy, playing a pivotal role in advancing vaccine portfolios from concept to commercialization.

A strategic thinker and dynamic leader, Kumar has spearheaded critical initiatives across the entire product lifecycle, ensuring seamless transitions from preclinical and clinical trials to market launch. He is actively engaged in global regulatory affairs, expanding vaccine access in international markets, and shaping the future of public health through cutting-edge vaccine innovations.

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Durga Prasad Erukulla working as Manager (Regulatory Generis Development) in Sandoz with overall 14years of experience in Regulatory Affairs department in various organizations, with this rich experience successfully submitted around 50 New Dossier submissions specially in US, EU, JP and some of ROW countries. His significant impact includes submissions without any rejection comments and the in-depth review of the sections that helps to avoid the major queries from Health authorities which benefits the industry to achieve first cycle approvals required for timely commercial launch of molecules for pioneering access to the patients.

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Profile Summary:

I am Passionate, forward thinking Regulatory Affairs Leader with 19+ years of pharmaceutical industry experience in the field of Global Regulatory Affairs, predominantly in Regulatory Affairs CMC with the increasing responsibility of portfolio and people management.

In current role, Stabilized and strengthen the capability of the RA CMC and Device department in Bangalore India, which involves hiring line managers, associate directors and experienced Regulatory professionals in Bangalore India. Heading a department that works defines regulatory and device strategies for biological, biopharmaceuticals, small molecule, and Medical devices content (data and documentation) requirements for regulatory submissions and review the content for conformance with established requirements to provide best in class regulatory CMC strategies to the projects we support, thereby ensuring fast submissions and approvals globally. Ensures team effectiveness in working across a very complex matrix environment in RA with CMC RA leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.

I am motivated by the opportunity to make a positive impact on the lives of patients and the society through innovation, collaboration, and excellence.

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Academic background; Pharmacist in first degree and MSc in 'Medicine regulatory affairs

Current positions; Vice chairman of East African regulatory affairs Professionals association (EARAPA) for the last two and half years.

Currently working as Senior medicine registration expert at Ethiopian Food and Drug Authority (EFDA) And Lead GMP auditor of pharmaceutical companies at EFDA, Conducted official EFDA GMP audit of more than 16 Indian pharmaceutical companies and more others worldwide.

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Martina Gomes is the Regulatory Head for Bayer’s Consumer Health Division in India. She has over 16 years of Pharma and Consumer Health industry experience working in organizations like Pfizer & Sanofi across diverse portfolio of Biologicals, Specialty, Animal Health, OTC, Nutritionals and Ayush for South Asian countries. In her various roles, she has had opportunities to work closely on Health Authority interactions, Registration strategies, International product launches, Product life cycle expansions, business growth strategies and various other organizational projects. Martina has been involved with several Trade associations (OPPI, FICCI, Assocham, IDMA) for the last 15 years and has worked on several representations and initiatives to shape the external regulatory environment.

Martina strongly believes in building a regulatory framework and sustainable healthcare solutions to enable our Indian consumers to be in charge of their health and foster Self-care in our country.

Martina post-graduated from Sophia College, Mumbai with a Masters in Microbiology and further a degree in Clinical Research from the Bombay College of Pharmacy, Kalina. She’s an active member on the Board of Studies of Sophia College since 2021. She joined Bayer India in July 2020. In her earlier stint, she was the Head of Regulatory Affairs CH for South Asia at Sanofi.

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• M.Pharm -Pharmaceutical chemistry, RGPV India
• Advance Executive course – Corporate Strategy and Business Leadership, IIM Indore, India (Nov-2024)
• Pharma industry experience – 18+ years
• Regulatory Intelligence experience – 10+ years
• Current role: Associate Director, GRA, Regulatory Intelligence and Compliance at Advanz Pharma, UK.
• Past Roles: Regulatory EU submissions, Regulatory Intelligence, Operational excellence at CIPLA Ltd. India
• Professional Associations – Active member - RAPS INDIA, TOPRA Regulatory Intelligence SPIN CHAIR - 2023 till date

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