Omprakash S. Sadhwani

Former Joint Commissioner & Drugs Controller Food and Drug Administration, Maharashtra

Former Member of Drug Technical Advisory Board (DTAB)
Expert in detection and investigation of cases
Faculty on trainings in investigation skills
Wide expertise in policy making for state FDA
30 years expertise in enforcement of Drug Laws
Gaurav Puraskar by Govt. of Maharashtra – 2008
Best Drug Control Officer of India by All India Drug Control Officers’ Confederation – 2010
COO, Tiblo Consultancy Services, Mumbai
Director, Xplore Heathcare Solutions LLP, Thane

Manoj Chitnis

Vice President (Corporate Quality Head), JB Pharma

Currently working as Corporate Quality Head at J B Chemical and Pharmaceutical Limited since December 2020
Designation – Vice President
Location – Mumbai
Overall work experience of Twenty-seven (27) years with,
§ Plant and Corporate
§ Manufacturing of Formulations, Active Pharmaceutical Ingredients (API) and Intermediates
Profiles handled during my career are,
Production
Quality Control
Quality Management Systems
External Manufacturing – Quality (Formulations & API)
Project management
Technology Transfer
Validation and Qualification
Vendor Development and Vendor Qualification
Dossier filing

Pradnya Deshmukh

President, Head Global Quality & Compliance, Wockhardt Ltd

Dr. Rajendra Chavda

Vice President & Head R&D and RA department BDR Life Sciences Pvt. Ltd.

Dr. Rajendra Chavda is Vice President of R&D and RA department in BDR Life Sciences. He has been in Pharmaceutical industry since last 23 years and worked in various reputed Pharmaceutical industry including Sun Pharmaceutical Industries Ltd., Zydus Cadila Healthcare Torrent Research Centre and Macleods Pharmaceutical Ltd. In his current role he provides regulatory guidance, manages and leads team in strategic decision making, ensuring quality submission to the Food and Drug Administration. He is mentoring team in development of API, Scale-up, technology transfer activity and Launch preparation of generic products. Dr. Rajendra has co-authored 31 national & international patents and 5 international publications. He has developed & scaled-up over 100 products and filed more than 35 EU & USDMFs and many products in CDSCO also. He has expertise in executing cost-saving techniques/measures to achieve substantial reduction in expenditures with proven success in Synthetic Organic Chemistry Research for the business of Bulk Drug for Regulatory as well as domestic market.

Dr. Narender Rao Somisetti

Vice President, Head-R&D, Metrochem API. Pharmaceutical

Dr. Narender Rao Somisetti is currently a Vice President, Head-R&D, Metrochem API.
Pharmaceutical professional having Core Competencies & Capabilities in API Process development. Skilled in Process Research & development of large volume Generic APIs and contract manufacturing in pharma. Currently works with Metrochem API and previously associated with Lupin Ltd, Piramal Enterprises Ltd, GVK Biosciences Pvt. Ltd and Dr. Reddy’s Labs. Successful in designing and developing robust and commercially viable processes for APIs through green chemistry and QbD approaches, principles of DOE and Quality Risk analysis. Seasoned professional having experienced in efficient scale up, Technology Transfer, anticipating and resolving API manufacturing problems on large scale. Experienced in Identification, synthesis and characterization of impurities of API. More 30 patents and 15 scientific publications are there to his credit.

Dr. Andiappan Murugan

Vice President, API at Troikaa PharmaceuticalsLtd

Ph.D from NCL, Pune (2002)
Postdoc from UT Southwestern Medical Center at Dallas, USA (2005-2006)
PMP and Six Sigma Black Belt certified
Scientist at NCL pune (2002-2006)
Team Manager at Hikal Ltd (2006-2008)
Senior Research Scientist at AstraZeneca Pvt Ltd, Bengaluru (2008-2014)
Associate Director at Dr. Reddy's Laboratories, Bengaluru (2014-2021)
Vice President, API at Troikaa PharmaceuticalsLtd (from 2021)

Dr Rakesh Ganorkar, PhD

Vice President- R&D at Hikal Ltd

Biography:

• MSc (Analytical Chemistry) from Pune University, followed by PhD degree in Chemistry (Synthetic Organic Chemistry) from University of Vermont, USA.
• Postdoctoral training from Rensselaer Polytechnic Institute, USA.
• Masters in HR management from NMIMS.
• An industrial experience of over 19 years including in India and Abroad. Mainly worked with companies like Unilever, Wockhardt, Syngene, Dr Reddy’s Laboratories, Biocryst Pharmaceuticals Inc, etc. Currently working with Hikal.
• Experience spans Synthetic Organic Chemistry, Chemical Process Development, Custom synthesis as well as Medicinal Chemistry, Analytical method development.
• Generic API development as well as development of NCEs.

Abhijit Roychowdhury

Director at Emcure Pharmaceuticals Limited

Dr. Roychowdhury graduated with a Ph.D. in organic chemistry from University of Georgia, USA. After graduation he went on to take up an industrial position in Sigma-Aldrich Corp. at their biotechnology research institute in St Louis, USA. His research yielded four commercial products in the field of glycobiology and proteomics. Dr. Roychowdhury moved back to India and joined Piramal Enterprises Ltd. where he led a group of medicinal chemists and supervised various drug discovery programs in the field of oncology. These efforts culminated to the discovery of a Phase I clinical candidate. Presently, at Emcure Pharmaceuticals Ltd. he leads the R&D team to focus on development of complex generics to bring affordable treatment options to the market. These efforts have led to the filing of various DMFs across geographies.

Dr. Roychowdhury’s is a registered Ph.D. guide at University of Pune. His research has yielded multiple patents and papers in journals of international repute. He has also been an invited speaker to various national and international institutes and conferences.

Arijit Das, PhD

Vice President & Global API R&D Head at Cipla

Rajni Jha

IIT Kanpur Scholar, Synthetic Organic Chemistry, Trainer for QBD, GMP & Regulatory Affairs

Paramvir Bhadwal

Head R&D API Farmson Pharmaceuticals

Pradeep Sharma

Head -Supply Chain & Network Strategy – Long Term Supply Chain Strategies for API Business Sun Pharma

Venkatesh Katgeri

Vice President at SRIKEM LABORATORIES Private Limited

Experience : 1992-2016

April 1993 - July 1993 in Cipla
Started my career in Quality control, as an analyst responsible for testing and release of raw materials,

August 1993- December 1996 in Cipla
Responsible as plant officer for API manufacturing, tech-transfer,

December 1996 to November 2002 in Cipla
Responsible as plant QA officer involved in Tech transfer, QA observer and reviewer, training, complaints site regulatory support, customer audits, Audits of API suppliers and review of audit related documents

November 2002 to November 2016 in Cipla , November 2016 to March 2020 in Glenmark
Responsible for global API Regulatory affairs, headed a team responsible for filing more than 75 USDMFs and 25 CEPs, WHO DMFs, filing EuDMFs , handling regulatory life cycle of DMFs, supporting formulation team for in-house as well as outsourced APIs,

April 2020 till date at Srikem Laboratories as a Vice President
Great learnings regarding the functioning of a MSME at Srikem Laboratories, Responsible for a team that looks after Regulatory, Quality, production, Engineering, and maintenance, Warehouse, new projects, R&D support, managing projects, compliance, training

Vijay Kshirsagar

Director, TRAC Pharma Consulting, Mumbai, India

Vijay is an accomplished Quality, Regulatory & Analytical professional with more than 45 years of rich experience of working for reputed Indian, MNC Pharma firms & as a Consultant . From 2006 to 2013, he worked for Unichem as Executive Vice President responsible for CQA, Regulatory & Analytical Research, based in Mumbai, where he continues to be as Advisor on Quality & Regulatory matters.

Prior to Unichem he worked for Ranbaxy, Sun , Lupin, IPCA, German Remedies in various senior positions like Director-Quality , GM-Quality etc . He has successfully represented his company in US and UK courts regarding IP related matters (Para IV filings).

Vijay has led from front for successful completion of several regulatory inspections by US FDA, MHRA, EDQM, ANVISA, WHO, PICS, PMDA, Health Canada, TGA etc. both for Drug Products (Non-Sterile & Sterile) & API’s. He has been a frequent trainer in India & abroad having spoken on wide range of topics including cGMP/ GLP/ PQS/QRM/Validations (Process, AMV, Cleaning, Microbiological) /QbD/ Dissolution/ Stability/ Handling Regulatory Queries/ Investigations/ CAPA/ Auditing/ Documentation/EM etc. He has an unique achievement of converting existing Cephalosporin facility to a general product facility & getting it approved by MHRA (first time in India).

He is the founder President of ‘Society for Pharmaceutical Dissolution Science’ He has also worked on the board of Directors of ISPE-India for 12 years. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis. He has been a Trainer for USP’s training programs for young pharmaceutical professionals and also authorised as a Trainer by HRDF, Malaysia.

He has published articles on topics like OOS, QbD & cGMP in reputed journals/books. His chapter on ‘OOS Investigations’ is a reference material being a part of the book for Pharmacy students. Guideline written by him on CAPA is published by IDMA. He is M.Sc. by Research in Organoanalytical Chemistry from Mumbai University. He has a good Microbiological background too having done his graduation with Microbiology. He is a Mentor to two reputed pharmacy colleges in Mumbai including BCP.

Post retirement in 2013, he has formed his own Pharma Consultancy called TRAC offering specialized services globally, for cGMP Training, Regulatory Filings, Auditing & Compliance. His current clients include reputed Pharma/API companies based in India, China, US, Europe, Turkey, Bangladesh, Malaysia etc. As a consultant, he has helped number of companies to get their first time international regulatory approvals & also sustain them over a long period. He is also advising some companies for their remediation plans to revive their regulatory approvals.

Dr. Shraddha Bhange

Medical Director Safety Science Pharmacovigilance Eversana

Dr. Shraddha Bhange is a doctor by profession with more than 10 years of experience in pharmacovigilance. She is currently serving as Medical Director and heading pharmacovigilance team of physicians at EVERSANA . She was recently selected as top 10 Medical officers 2022 and her story is featured on cover page of "Women Entrepreneur Magazine".

She has worked in core pharma companies such as NOVARTIS, Wockhardt, AB Science (French Biopharma based in PARIS) and CRO/IT like Cognizant.

She has worked in India and Europe (Paris) and faced various regulatory inspections and worked in various therapeutic areas such as vaccine, oncology, diabetics, neurology, and generics. She has worked on postmarking and phase I to phase III drugs and supported product approvals in US, Europe and India. Shraddha is skilled in various regulatory/health agency regulations, especially USFDA, EMA, MHRA, and DCGI. Her other areas of interest are medical communications, quality assurance, regulatory requirements, audits and inspections.

Dr. Bhange earned her Bachelor of Medicine and Bachelor of Surgery (MBBS) from the Maharashtra University of Health Sciences (MUHS) under the Medical Council of India (MCI), and completed a specialized postgraduate full time program in paraclinical subjects, Msc Biomed tech from Coventry University, United Kingdom.

Dharmesh Kharwar

M. Pharm, MMM, CLP-Emeritus, PGP-AIFL Independent Director & Strategy Advisor Director NGB Laboratories

Mr. Dharmesh Kharwar is an Independent Director and Strategy Advisor with focus on Healthcare Sector. Dharmesh has broad experience of more than 28 years of Extensive Cross-Functional Capabilities. He currently is KMP for NGBLPL’s export-import of pharma, nutraceuticals and devices. His other interests are

• Strategy : market entry, expansion, transactions ( multiple international clients ) M&A : Integration of multiple corporations
• BD : In and out licensing, co- marketing, brand launches and life cycle management, tenders
• Legal : Patent, pricing, statutory litigations
• Manufacturing & Procurement : Product development & tech transfer, registrations, commercial supplies of inputs and output materials to meet exact specifications and needs.
• Public platform :Engagement /speaking/ shaping policy
• Compliance : Building and sustaining strong systems and teams.
• Commercial : Import, export, registrations & sourcing
• Due diligence : Plants, products, personnel, processes, procedures, approvals, intellectual property for clients like banks, PE, promoters ( both sides)

Masters Degree in Pharmaceutics from Department of Pharmaceutical Sciences, Nagpur University

MBA from Jamnalal Bajaj Institute of Management Studies (JBIMS)

CLP® Emeritus, USA & PGP-Artificial Intelligence For Leaders, Univ of Texas Austin USA. His previous assignments included position of Director at Janssen – J&J, Director, MSD Pharmaceuticals Pvt. Ltd. ( A Subsidiary of Merck & Co. Inc, USA), and recently as Director NGB Laboratories Pvt Ltd. Ex OPPI & AMR Industry Alliance member & Life Member Indian Pharmaceutical Association

Dr. Roshan Palewar

Bhartiya Ratna & Pharma Ratna Awardee, {M.S., M.D., Ph.D.(Psy), EMDP-IIM, PMP, MSP, BI, 6σ, DOM, DPM, CHP, LPB, , ABCP, ACLS, DSHMPH, MSNT(Stanford) Global Scientist, CEO, Pharma Global Leader, DocRoSh Global Solutions, Mumbai

Meet Dr. Roshan Palewar - a true powerhouse in the world of medicine and pharmaceuticals. With a seemingly endless list of qualifications and accolades to his name, Dr. Palewar is a Bhartiya Ratna and Pharma Ratna awardee, holding over 20 degreesincluding in M.S., M.D., Ph.D., MSNT (Stanford), EMDP-IIM, PMP, MSP, BI, 6σ, DOM, DPM, CHP, CPB, ABCP, ACLS, DSHMPH and more.

With over 17 years of experience in the field, Dr. Palewar has made a significant impact as a respected entrepreneur, Global Pharma Leader, Advisor, Mentor, Global Scientist, Researcher, Formulator, Doctor, And Psychologist. He has researched and developed over 400 medicines and launched a wide range of pharmaceutical products across the US, Europe, APAC, LATAM, and CEEMEA regions. But Dr. Palewar's influence extends far beyond just his professional accomplishments. He is also a renowned international speaker, having been invited to speak at over 300 National & International Events. He has led a team of 600+ Global Scientists and has operated in 172 countries. He has also mentored and placed over 24,000 aspiring professionals across the industry.

Dr. Palewar holds prestigious positions such as Council Member at GLG in New York, Knowledge Partner at Lynk Global in Hong Kong, and Expert Healthcare Advisor at GuidePoint in New York. He is also an Expert Healthcare Industry at Infollion Research, Expert at IAAIL Insight Alpha's Association of Industry Leaders, Expert at Stratlancer, Expert Pharma Industry at Experts Network, Expert Pharma Advisor at ProSapient in Philippines, Expert Council at FirstThought in New York, Expert Pharma Advisor at OnFrontiers in New York, Expert Healthcare Advisor at The Smart Cube in England, United Kingdom, Expert Healthcare at Ivy Exec in New York, United States, Expert Healthcare Advisor at Coleman in Chicago, United States.

But perhaps most impressively, Dr. Palewar has been recognized for his contributions to the industry, having received 1000+ awards such as the Bhartiya Ratna Award, Pharma Ratna Award, Lifetime Achievement Award, 100 Most Impactful Healthcare Leaders- Global Award, Top Pharma Innovation Award, Healthcare Leadership Award, India Leadership Brilliance Award, Best Healthcare Award, and has been honored by the Health Minister.

With such an impressive profile and a track record of success, it's clear that Dr. Roshan Palewar is a true leader in the field of medicine and pharmaceuticals. His contributions to the industry are undeniable and his work will continue to impact and inspire future generations to come

Rajan Sundavadra

Product Architect

Rajan has a Masters of Computer Applications degree together with close to 15 years of experience in developing diverse products in the serialization and Track & Trace industry. He is an expert in creating enterprise application using GS1 Standards, employing different technologies such as Java, Angular, Sprint, Hibernate, Postgres SQL, MySQL, SQL Server. He is also an expert in deploying enterprise application on Azure cloud with Disaster Recovery Solutions.

At Jekson, Rajan has developed highly-functional and integrated systems including a ReeTrak – serialization software at plant level, ReeSource – corporate Serial Manager, as well as ReeSmart –iOT solutions to make manufacturing smarter.

Apart from working as an SME- Serialization, Rajan plays a crucial role in helping Jekson’s clients identify effective and optimum software solutions that help them solve their specific business problems. Working closely with the sales teams to facing the customer, Rajan also plays a part in optimizing processes through personalized digitization and intelligent automation solutions.

Deepa Pangaonkar

Global Head IT Wockhardt Ltd PHARMA

Dr. Ashok Kumar

President, Centre for Res. & Dev. Ipca Laboratories Limited

Dr. Ashok Kumar carried out his Ph.D. work at CDRI, Lucknow under the supervision of Padmashree Dr.Nitya Nand. This was followed by Post-Doctoral studies with Prof. Sir John Cornforth CBE,FRS a Chemistry Nobel Laureate, at the University of Sussex, England from 1981-1984.

He started his carrier with Alchemie Research Centre at ICI, Bombay in 1985 and served Lupin Laboratories before taking up the job with Ipca Laboratories Mumbai, a leading Pharma Company in the year 2000 and is presently heading the Centre for Research & Development of Ipca in the capacity of President.

He is a co-author in more than three dozen papers published in peer reviewed International Journals, co-inventor in more than 150 patent applications filed, has presented Scientific Papers and Keynotes in many National / International Conferences in addition to delivering Invited Talks on R&D Management, Idea Management, Innovations, Role of Common Sense and Philosophy in Discovery / Research and many more such topics.

Ashok Bhattacharya

Former Executive Director, Takeda Pharmaceuticals

Krishna A

Industry Consultant, Life Sciences, Rockwell Automation India

Ankit Jain

Industry Consultant (Asia Pacific), Life Sciences, Rockwell Automation India

Sarang Bhunje

VP Head Quality Operations API, CIPLA

Kumaresan M

Unichem Laboratories CIO / Head of Information Technology