6th Annual Pharma Regulatory Summit 2023
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Speakers
PRATIK SHAH
Bharat Serums and Vaccines
PRATIK SHAH
Bharat Serums and Vaccines
PRATIK SHAH, VP - Medical Affairs, Bharat Serums and Vaccines
AVINASH R K
Cipla
GEETA S
Ipca Laboratories
GEETA S
Ipca Laboratories
GEETA SHANBHAG, Vice President - Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories
• A management post graduate with pharmacy background, she has around three decades of experience in pharmaceutical industry, inclusive of medico-marketing, regulatory affairs, clinical research, bioequivalence studies, pre-clinical studies and pharmacovigilance.
• She is a proactive team player with strong planning skills, critical/ analytical thinking, multitasking, problem solving, and team management skills.
• From past 14 years, she is involved in pharmacovigilance. She has been instrumental in setting up in house pharmacovigilance department in Ipca, which handles end to end pharmacovigilance on global scale.
• She has hands on experience on both Aris G and Argus database, data migration, case processing, medical writing in pharmacovigilance, audits and inspection. In fact, Ipca successfully cleared its first US FDA pharmacovigilance inspection in 2017.
RAHUL GUPTA
USV
RAHUL GUPTA
USV
RAHUL GUPTA, Sr. Vice President – Regulatory Affairs, USV
• Rahul Gupta is presently Senior Vice President – Regulatory Affairs at USV Pvt Ltd. Prior to USV, he has worked in Sun Pharma, Piramal enterprise and many other pharmaceutical companies.
• Rahul has over 25 years of experience in the various pharmaceutical area. He has regulatory experience for development of new molecules from discovery to Phase I to Phase III.
• He has worked on cancer, anti-analgesic, anti-infective, metabolic disorder drugs in area of new drug development- having experience of successfully filing about 60 Phase I / II and III IND / CT applications across various continent, which includes USA, Europe, Australia, Canada and India.
• He has also worked on more than 70 ANDA’s and generic European submission for various dosage form- solid orals, parenterals, nasal sprays and complex generics etc, also having experience of DMFs/CEPs/ASMFs in regulated countries.
• He is M.Sc in Pharmaceutical chemistry and MBA in Operational management. He was also an adjunct faculty at Mumbai University (Bombay college of pharmacy), NMIMS and many other academic institutes in India.
SOFI JOSEPH
Servier
SOFI JOSEPH
Servier
SOFI JOSEPH, Regulatory Affairs & Pharmacovigilance Director, Servier
An established professional with over 25 years of experinece in Regulatory Affairs, Pharmacovigilance, & Clinical Trials; acknowledged for providing strategic direction for the Regulatory, Pharmacovigilance (PV), Clinical Operations, New drug development & Due diligence of pharmaceutical products
• Product registrations, their lifecycle maintenance and defense.
• Clinical operations and Pharmacovigilance
• Strategy and Project planning
• Coordinating and supporting the implementation of regulatory strategies to ensure successful on time submissions
• WHO prequalification’s and Emerging markets submissions
• International as well as Domestic Regulatory filing and health authority interactions
• Expertise in regulatory filings for Clinical trials, BA/BE studies, New Chemical entities, Active Pharmaceutical Ingredient ( API) , Formulations, Biotech Products, Cosmetics and Food supplement
• Environmental shaping with industry bodies and health authorities
• Audit and compliance
• Due diligence for in-licensing / out-licensing molecules
• Product development
Organizations worked with in the past: Torrent Pharmaceuticals, Hester Biosciences, Biological Evans, Glenmark Pharmaceuticals, Pfizer Limited.
Current Organization: Servier India Pvt Ltd since April 2017 as Regulatory and Pharmacovigilance Director (Formerly known as Serdia Pharmaceuticals ( India ) Private Limited)
Educational: Master’s Degree in Pharmacy form L.M College of Pharmacy, Ahmedabad , Diploma in Regulatory Affairs and Certification in advanced clinical trial monitoring
MILIND ANTANI
Nishith Desai Associates
MILIND ANTANI
Nishith Desai Associates
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
• Dr. Milind Antani is a Leader of the Pharma & Healthcare Practice a at the multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi and Mumbai – BKC, Munich and New York. He is also partner in-charge of Social Sector practice and Nanotechnology practice.
• Dr. Antani represents clients on strategy matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation, collaborations including joint ventures and formation of new companies. He also advises clients in e-Health and tele-medicine on business strategy from legal and regulatory perspective.
• He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS, and Pharma and Life science. The have also contributed a chapter on India in ‘Commercialization of Healthcare-2nd Edition Global Guide’ published by Thompson Reuters in 2015. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, biotech, IP, clinical trials, healthcare, CSR, FCRA. He is also a visiting faculty at many institutions in Mumbai.
• He has been included as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2014 and 2015 in the ‘Regulatory’ section as only lawyer from India.
• Dr. Antani practiced as an ENT surgeon for 14 years prior to joining Nishith Desai Associates as a lawyer.
• He has also successfully attended "Managing and Transforming Professional Service Firms-India” an executive training program organized by HARVARD BUSINESS SCHOOL.
ANJU AGARWAL
Advanz Pharma
SHIRAZ K
Ferring Pharma
SHIRAZ K
Ferring Pharma
SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Ferring Pharma
• Done Masters in Biotechnology.
• Currently working as Associate Director – Regulatory Affairs at Ferring Pharmaceuticals Pvt. Ltd. Responsible for regulatory and pharmacovigilance activities of India and South Asia.
• Previously worked in organizations like Abbott healthcare, Sanofi Pasteur, etc.
• Industry experience of about 26 years
DILIP PAWAR
Unichem Laboratories
DILIP PAWAR
Unichem Laboratories
DILIP PAWAR, Global Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
Heading Medical Affairs, PV and Global Clinical Development. I am oncologist and also Covid Expert
BOBBY GEORGE
Reliance Life Sciences
BOBBY GEORGE
Reliance Life Sciences
BOBBY GEORGE, Vice President & Group Head Regulatory Affairs, Reliance Life Sciences
“Dr. Bobby George is Vice President & Group Head of Regulatory Affairs at Reliance Life Sciences, Mumbai. He did his B. Pharm from Manipal, and went on to do M. Pharm and Ph.D. in Pharmacology from Panjab University, Chandigarh. He has also completed Senior Management Program from IIM, Kozhikode. Dr. Bobby has over 25 years of industrial experience. He started his career at Dabur Research Foundation, Sahibabad where he worked for 5 years in their clinical research division on oncology drugs. He then moved to Reliance Life Sciences and has been associated with them for over 2 decades now.
At Reliance, he is responsible for all their regulatory services across Pharmaceuticals, Biosimilars, Blood products and Vaccines in both domestic and export markets. He is the recipient of several awards like IDMA award, CL Malhotra award, Jewel of India award etc. Dr. Bobby has to his credit 36 publications in both national and international peer reviewed journals. He has authored 4 book chapters apart from authoring a book on healthcare laws and reforms called “The Act that Wasn’t”. He is also on the editorial board for an international peer reviewed pharmaceutical journal. Apart from being a writer, he is an avid speaker and has delivered multiple presentations at both national and international forums.”
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Deepa is an Experienced Clinical Development and Drug Safety physician. She served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities. Currently she is the Chief Executive Officer of Clinexel Life Sciences Pvt Ltd.
CLINEXEL is an agile, customer focused full service, Clinical Research Organization, that provides clinical research, pharmacovigilance, regulatory, auditing and medical writing services to pharma, biotech and medical device companies. At CLINEXEL, our mission is to partner with early-stage pharma and biotech companies for fast and efficient clinical development of their innovations.
SWEETY MATHEW
Novo Nordisk
SWEETY MATHEW
Novo Nordisk
SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare, Disease, Novo Nordisk
• Sweety Mathew is part of Global Regulatory Affairs- CMC Rare Diseases team in Novo Nordisk and was earlier associated with Biocon Biologics handling peptides and biosimilars.
• Prior to being a Regulatory professional, she was associated with BioMarin Pharma- UK (Rare Diseases) and part of RnD team as a Cell and Molecular Biologist.
• She is a post graduate in Bioinformatics and Applied Biotechnology from University of Westminster, London.
• She believes in nurturing an inquisitive and an explorative culture to be part of this exciting race to create a more scientifically advanced tomorrow.
RANJIT B
QBD International
RANJIT B
QBD International
RANJIT BARSHIKAR, CEO, QBD International, United Nations Adviser
In a career span of 51 years, have rich & varied experience in the Pharma Industry, especially in Quality Management, R&D, Mfg., Regulatory, US FDA / EU / WHO etc. compliances.
Major Awards:
- “Quality Champion - Gold” Topmost Quality Award by Govt. of India - Quality Council of India.
- “Lifetime Achievement” Award by International UNICEF Council- USA “.
- “100 Most Impactful Healthcare Leaders -Global” Award by World Health Congress / ET. etc.(in addition to 34 other awards)
- Invited as “Jury” by Economic Times for ET Healthcare Awards 2022.
Currently:
- CEO- QbD International (Quality by Design / CGMP Consulting -- Bio-Pharma / Pharma).
- United Nations- MPP Geneva Adviser since January 2019.
- Member of Editorial Board of Journal of Generic Medicines – England.
- Expert on Quality by Design / Data Integrity / CAPA / Quality Culture, Regulatory & various other CGMP subjects. Expert Auditor of “Formulations” & “API” facilities / CRO etc.
- Worked as Quality Expert with World Bank- Washington USA. Worked with Saudi Arabia FDA for generating the regulations and training SFDA inspectors on behalf of World Bank.
- Travelled Globally to 70 countries & delivered 515 + presentations in Conferences, as Chairman or Keynote Speaker or Speaker, organized by ISPE FDA, Marcus-Evans, IQPC, IPC, CBI ( USA) , WHO, ISO, UNOPS, Govt. of India, CPHI , FDA of Gujarat, Maharashtra, FDA - AP, FDA - Karnataka etc.
- Addressed 104 Webinars till date in last 18 months on Covid19 & various Pharma subjects. Have articles / interviews, published in various International Journals like Pharmaceutical Manufacturing-USA, Pharmaceutical Technology-Europe, and Pharmaceutical Technology-Asia, Digital version to mention few.
- Was nominated as an IPA expert Geneva, for new “ICH Expert working Group-Geneva, on CTD QOS”. Served as member of IPA, IDMA, ISPE, Gujarat council of Bio-Technology etc. Worked also as a faculty member of OPPI, IDMA, ISO workshops & was member of “GMP committee for API” by DCGI (Govt. of India).
- Advisory committee member of: SVKM’s Bhanuben Nanavati Pharmacy College – Mumbai, DYPatil University Pharmacy College -- Talegaon & Nerul, NM Sattha College of Pharmacy at Ahmednagar, Maharashtra.
- Mentor of Geetanjali University Udaipur - Student Chapter of ”International Society of Pharma economics & Outcomes Research” (ISPOR).
- Worked with PFIZER LTD./ Sun Pharma (Ranbaxy) / Lyka Labs, Cancer Research Institute Mumbai. Retired as “Global Quality Head / Vice President” in 2006.
BINDHU LATHIKA
Biocon Biologics
BINDHU LATHIKA
Biocon Biologics
BINDHU LATHIKA, Associate Director - Pharmacovigilance, Biocon Biologics
• She is a dynamic multifaceted physician, with extensive work experience of over 21 years in the Healthcare domain with a strong emphasis on Pharmacovigilance/ Drug Safety & Clinical Research in the Global Pharmaceutical Industry & Clinical Research Organisation.
• She is the Lead for Medical Safety in Biocon Biologics Pharmacovigilance. She is equipped with robust medical knowledge, global regulatory authority guidelines & their requirements with expertise & experience in end-to-end Global Pharmacovigilance/ Drug Safety & Risk Management activities for both clinical and post-marketing safety.
DARREN P
Nishith Desai Associates
DARREN P
Nishith Desai Associates
DARREN PUNNEN, Leader, Pharma and Life Sciences Practice, Nishith Desai Associates
AREAS OF PROVEN EXPERTISE
Darren’s practice focuses on advising several multinational and domestic clients in the pharmaceutical, med-tech and life sciences industry on commercial, regulatory, litigation, investment, white collar and intellectual property matters. He regularly advises a variety of life science companies in navigating commercial, legal and regulatory hurdles in the Indian market in relation to clinical trials, imports and manufacturing/contract manufacturing, marketing and promotion, distribution, licensing, retail and HCP interaction. Darren also represents multiple pharmaceutical and medical device companies for various regulatory and commercial litigations.
Darren has been recognized as an expert in the field by international legal directories including Chambers & Partners, Legal500 and Asia Law. Darren also the consulting lead for the IP & Legal working group for a leading MNC pharmaceutical industry association and has regularly been invited as speaker and panelist for various events in the pharmaceutical and healthcare industry, including medical devices and digital health.
PUBLISHED AUTHOR
Darren regularly contributes to national and international publications, writing on various topics including pharmaceutical, medical device and healthcare regulations, med-tech and digital health. Darren also regularly contributes to widely read healthcare publications such as Express Pharma and Thomson Reuters and has also prepared various guidebooks ranging from medicinal product regulations to pharmaceutical and medical device regulatory, intellectual property and competition law framework.
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI, Director and Head – Clinical Study Unit, India and South East Asia, Sanofi
• Dr. Vaibhav Salvi is a physician by training with specialization in Electro-cardiology.
• He has more than fifteen years’ experience in clinical research and drug safety.
• His research work has been presented at national conferences (Cardiological society of India, Indian Society of Medical Statistics, The Chennai Paediatric Electrophysiology Symposium) and international conferences (Drug Information Association, Statisticians in Pharmaceutical Industry, International Congress on Electrocardiology).
• He has more than a dozen publications to his credit published in journals like British Journal of Pharmacology, Journal of Pharmacology, Journal of Electrocardiology and Diabetes Care to name a few.
SADANAND K
Fresenius Kabi
SADANAND K
Fresenius Kabi
SADANAND KULKARNI, Head - Medical, Regulatory, Vigilance, Quality, Fresenius Kabi
Current Position
- Head, Medical, Regulatory, Vigilance, Quality, Fresenius Kabi India Pvt. Ltd., since Jan 2019
Professional experience:
- Vice President, Medical Affairs and Clinical Research, Fresenius Kabi India Pvt. Ltd., Pune/Gurgaon: July 2011 to 2018 (with Fresenius Kabi, since 2003)
- Assistant Medical Director, Serum Institute of India, Pune., Sept 2000-May 2003
- Teaching profession: February 1996 - August 2000
- M.D. (Clinical Microbiology): 1995: BJ Medical College, Pune
- DIB (Diploma in International Business) 2003: Symbiosis Institute of International Business
- Trained in clinical nutrition and volume therapy, Fresenius Kabi Advanced Nutrition course and Fresenius Kabi Advanced course in transfusion alternatives
Clinical/research interests:
- Co author of papers presented in ESPEN 2004, 2005, PENSA 2003, NATA, 2006 in the field of Clinical Nutrition and Volume Therapy
- 4 publications in the field of Clinical Microbiology and Vaccinology
Special areas of interest:
- Clinical Nutrition and immunonutrition
- Hospital acquired infections
- Clinical trials under GCP
NEERAJ M
Sun Pharma
NEERAJ M
Sun Pharma
NEERAJ MARKANDEYWAR, DGM-Medical Affairs, Sun Pharma
• Currently working as Lead Medical Affairs, Sun Pharma, Mumbai
• Completed MBBS from GMC Nagpur; MD Pharmacology from KEM Hospital and Seth GSMC, Mumbai; DBM from Welingakar Institute, Mumbai
• 11+ years of Pharmaceutical Industry Experience (GSK, Sun Pharma)
• Worked on 21 pre-clinical, clinical, real world evidence studies in various capacities
• 7 publications in national and international journals and 7 poster and oral presentations in national and international conferences
• Contributed as editor for the Book “Pharmacology Made Easy”
• Presentations at various National conferences and workshops
• Contributed as full time volunteer at Americares India Foundation which provides essential healthcare to slum dwellers in Mumbai
APARNA P
Wockhardt
APARNA P
Wockhardt
APARNA PRABHUNE, Asst General Manager Regulatory Affairs, Wockhardt
Regulatory Affairs Expert with 18 years’ experience in handling regulatory activities for ROW markets, including Asia, Africa, CIS and America.
Have worked with companies like Cipla, Khandelwal Labs Pvt Ltd and Merck Ltd. At present working as AGM- Regulatory Affairs with Wockhardt Ltd.
Responsible for handling all in all Regulatory activities for India business for NCEs, ND, SNDs, Medical devices, Cosmetics and Food Supplements.. Also have expertise in Pharmacovigilance, Strategy planning for new product launches.
“Recent regulatory developments to explore innovative strategies”
Conference Schedule
Meet and to network with your conference colleagues.
08:30 – Coffee and Registration – An opportunity to meet and to network with your conference colleagues.
MARKET OVERVIEW & ANALYSIS
09:30 – Clinical Program Management
• Clinical Program Management Strategies – Pitfalls
• Clinical Development Strategies
• Clinical Trial Strategies
• Clinical Program Management – New Biotech, Small Generic Pharma and Big Pharma
MUKESH KUMAR, Senior Vice President & Head, Clinical R&D, Cipla
CHALLENGES & OPPORTUNITIES
10:00 – KEYNOTE PANEL DISCUSSION: Current regulatory compliance issues & opportunities for regulatory authorities & industry
• The Pharma Regulations in India: The Good, The Bad, The Ugly
• Overviewing the current regulatory landscape in - New regulations in picture and the way forward
• Regulatory updates and compliance challenges
• How pharmaceutical companies can accommodate and manage constant regulatory changes?
• How digital applications conflict with the legal and regulatory landscape?
• Are regulations becoming strangulations for Pharma sector in India?
Moderator
RANJIT BARSHIKAR, CEO, QBD International, United Nations Adviser
Panellists
GEETA SHANBHAG, Vice President - Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories
VAIBHAV SALVI, Director and Head – Clinical Study Unit, India and South East Asia, Sanofi
SADANAND KULKARNI, Head- Medical, Regulatory, Vigilance and Quality, Fresenius Kabi
BOBBY GEORGE, Vice President & Group Head Regulatory Affairs, Reliance Life Sciences
NEERAJ MARKANDEYWAR, DGM-Medical Affairs, Sun Pharma
11:00 – Morning Coffee / Tea & Discussion
CLINICAL
11:20 – DISCUSSION WITH EXPERTS: Regulatory updates towards recent clinical developments – The new normal
• Current approaches for clinical development strategy
• Regulation updates and evolving clinical trials approach
• Remote trials – finally the reality
• Regulations on trial guidelines, safety, approval
• Clinical evidence for regulatory purposes
• Using randomized clinical trials for regulatory purpose to generate real-world evidence
• Overcoming the main challenges of filing variations in India
• Industry and gov authorities – Working together
Moderator
DILIP PAWAR, Global Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
Panellists
RASHMI HEDGE, Executive Vice President – Medical, GSK
RAHUL GUPTA, Sr.Vice President, Regulatory Affairs, USV
NITIN CHANDURKAR, Vice President, Clinical Research and Development, Ipca Laboratories
YASMIN SHENOY, Senior Director - Regulatory Affairs, Sanofi
SEEMA PAI, Director Clinical Site Operations – India Cluster, Pfizer
12:10 – Global Clinical Development- Review of multi-country data by the regulators – Perspectives, Challenges and Solutions
• Optimization of Global Clinical Development
• Key role of study design and country selection in time and cost optimization of Clinical trial
• Perspectives of the USFDA, EMA and PMDA in reviewing multi-country clinical data- challenges and solutions
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
12:40 – Networking luncheon
PATIENT SAFETY
13:50 – DISCUSSION WITH EXPERTS: Prioritizing patient - Safety regulations
• How could regulations and guidelines be implemented in patient safety?
• Encouraging the patient for direct reporting the adverse effect on drugs
• Recent regulatory requirements in India for reporting of ADRs?
• New regulations on patient safety Comprehensive Guidelines for clinical and hospitals under new normal
• Open communication to ensure patient retention during clinical testing
• Ensuring the proper information delivered to patient regarding the trial or study.
Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
Panellists
ATUL NASA, Pro Vice Chancellor, SGT University (Former Drugs Control Officer, Drugs Control Department)
AVINASH R. KAKADE, Vice President & Head of Pharmacovigilance, Cipla
ANJU AGARWAL, Director, Global Patient Safety, Advanz Pharma
BINDHU LATHIKA, Associate Director - Pharmacovigilance, Biocon Biologics
SOFI JOSEPH, Regulatory Affairs & Pharmacovigilance Director, Servier
SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Ferring Pharma
14:50 – Regulatory considerations for Novel and Biosimilars
• Introduction to Biosimilars and complex molecules and how different they are
• Overview of Regulatory framework for Biosimilar development
• Robust CMC package
SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare Disease, Novo Nordisk
15:20 – Afternoon Tea / Coffee
15:40 – How to use real world data in regulatory applications
PRATIK SHAH, VP - Medical Affairs, Bharat Serums and Vaccines
MEDICAL DEVICES
16:10 – DISCUSSION WITH EXPERTS: Evolving opportunities and challenges in medical devices regulations
• A review of current medical device regulations in India and the way-ahead
• Challenges in securing authorization from authorities for medical devices
• Better understanding of assessment and technical documentation for approval of medical devices?
• New regulatory framework for clinical investigation of medical device.
• Key themes for drug and medical device combination
• Clear specifications for registration and regulation of pharmaceutical medical devices in India
• Regulatory policies and technological innovation in medical devices – Where are we heading?
Moderator
DARREN PUNNEN, Leader, Pharma and Life Sciences Practice, Nishith Desai Associates
Panellists
MAYUR PARMAR, Drugs Inspector, FDA (Deputy Collector, Gujarat Government)
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
HARSHAD KOTHAWADE, Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck KGaA
APARNA PRABHUNE, Asst General Manager Regulatory Affairs, Wockhardt
17:00 – Closing remarks and end of conference
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Sponsors & Partners
CLINEXEL Life Sciences
CLINEXEL is a full service CRO. We provide science driven customized, cost- effectiveand time sensitive efficient early phase clinical development solutions. We are providing end to end clinical trial, regulatory, pharmacovigilance and medical writing services to pharma, biotech and medical device companies.
CLINEXEL Senior Management have strong experience in large pharma and biotech companies therefore, understand the business needs and challenges of clinical development, and key aspects of life cycle management of pharmaceuticals.
We are supporting small and mid-size pharma and conducting Phase 1, 2 and 3 Clinical Trials for NCEs and Biologicalsand Pharmacovigilance regulatory compliance activities.
Visit our website: www.clinexel.com
CHITKARA University
Chitkara University has been established and managed by passionate academicians with the sole mission of making each and every student “industry ready”. With more than 25,000 students and 1,700 staff from over 100 different countries, the university is proud of the impact that its graduates, life-changing research, and innovative campuses and industry developments have made – both in India and around the world.
Chitkara University has been awarded the rating of A+ by the prestigious National Assessment and Accreditation Council (NAAC), which places it among the 5% of higher education institutions (HEIs) in India to be granted such a coveted grade.
Chitkara University has consistently ranked high in the coveted NIRF Rankings under various categories including Engineering, Pharmacy, Management, Overall and Research etc.
The university maintain close links with leading blue-chip companies and professional associations to deliver their academic programs, ensure that the courses are relevant and practical to deliver the skills in demand, allowing the graduates to hit the ground running.
Both the Punjab and Himachal Pradesh campuses have been rated as one of the best in the country. The universities programs rank among the nation’s elite: Management, Computer Science Engineering, Pharmacy, User Experience and Optometry to name a few.
Visit our website: www.chitkara.edu.in
ANCILLARIE
• Ancillarie is an ISO 9001: 2015 certified global clinical research support service company established in 2012. We provide clinical support service to Contract Research Organization (CRO), Biotechnology and Pharmaceutical companies to accomplish their goals. We have presence in Canada, India and with our partnering companies, we are in Eastern Europe and Latin America.
• Our goal is to provide professional clinical support service to our clients from all over the globe with investment in modern technologies, development of individuals supporting us and our partners.
• Our Processes are aligned with the statutory and regulatory standards and we are aiming to grow and gain attention as best clinical support service company in the market.
Our service portfolio includes:
• Clinical Operations
• Clinical Data Management
• CDISC Implementation & Mapping
• Biostatistics
• Statistical Programming
• Medical Writing
• Pharmacovigilance
• Quality Assurance
• Resourcing
Visit our website: www.ancillarie.com
Amplexor Life Sciences
• AMPLEXOR Life Sciences is a global provider of regulatory, quality and safety software solutions, serving and trusted by pharmaceutical, biotechnology and medical device companies for over 25 years.
• Its holistic Life Sciences Suite solution helps life sciences organizations to be efficient with launching products and breaking into new markets quickly while ensuring quality, efficacy and safety through end-to-end support to product lifecycle processes, data and content management.
• Life Sciences Suite is powered by the Compliance Foundation platform, which enables unified management of data, content and processes in a familiar user interface combined with powerful automation engine that drives complex process automations, migrations and integrations suitable for both cloud and on-premises deployment models.
Visit our website: www.amplexorlifesciences.com
Clinevo Technologies
Clinevo Technologies is an IT firm that provides regulatory compliance and user-friendly cloud-based Software Solutions for Clinical Trials and Drug Safety / Pharmacovigilance to over 100+ Pharma/CROs.
Clinevo solutions, through their Integrated Clinical Trial Platforms, can help Clinical Trial companies conduct Decentralized Clinical Trials and Virtual Clinical Trials in a highly efficient manner.
Clinevo Cloud-based software and 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.
Clinevo Technologies has a reputation for delivering solutions faster than majority of providers in this domain. Furthermore, they offer cost benefits that are unrivalled!
Some of their cloud-based Software Solutions are listed below:
Clinical Trial Systems
• Clinical Trial Management System (CTMS)
• Electronic Trial Master File (eTMF)
• Electronic Data Capture (EDC)
• eConsent
• ePRO/eCOA
• Randomization / IWRS
Drug Safety Systems
• Pharmacovigilance Database with AS2 Gateway
• Signal Detection
• Case Intake with MICC and Web Intake
Quality Management Systems
• Document Management System (DMS)
• QMS – CAPA, Change Control, Deviations and Audit Management
• Training Management / eLearn
Visit our website: www.clinevotech.com
Advent Chembio
Company Introduction
ADVENT CHEMBIO PVT LTD is a Navi Mumbai (India) based Chemicals Manufacturing Company. Ours is a young organization started almost 10 years ago by a team of professionals from the Fine Chemicals industry with a combined experience of more than fifteen decades and we are rapidly expanding our footprints across the globe.
Our product portfolio includes a wide range
• Fine & Specialty chemicals encompassing hosts of Inorganic salts,
• Analytical reagents,
• HPLC grade solvents,
• GC grade solvents,
• GC Secondary standards (traceable to USP/EP/BP),
• Ion-pairing reagents,
• Electronic grade products,
• Research Chemicals
• Building Blocks,
• Advanced Intermediates and
• Pharmaceutical Impurities including working standards,
o Certified Reference Standards
o Traceable Working Standards
o In House Working Standards
o Drug Impurities
o Standards Required for BA/BE studies
o Metabolites
o Labelled Compounds
o Drug Glucuronides
Kindly make a note that, we will provide you characterisation reports as per your requirements like CoA, HNMR, MASS, HPLC, IR, TGA / Moisture Content, Defined Potency, 13cNMR, SER, CHNS will be provided as per individual requirements
We have 2 manufacturing plants in Navi Mumbai (India) and a distribution network spread across the Globe. In addition to it we also manufacture pharmacopieal labelled solvents like IPA, MDC, Acetone, Glycerol etc as per USP/ EP/ BP/ IP/ JP.
For detailed list of products, please visit our website i.e. www.adventchembio.com
Any type of requirements please contact us on following contact details:
Mobile: +91-9136902597
Email ID: sales@adventchembio.com; marketing1@adventchembio.com
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Testimonials
DocRoShGlobal Solutions CEO, Pharma Global Leader
Novo Propharma Manager
Dr. Reddy’s Labs Director – India RA
Venky’s (India) Sr. Quality control Manager
Zuventus Healthcare Clinical Research Associate
Aristo Pharmaceuticals Assistant General Manager
Pharmnova Medical Director
Eris Oaknet Healthcare Executive QA
Advent Chembio Co-Founder & Director – Technical
Neon Laboratories Regulatory Head – Sr. Manager
Neon Laboratories Assistant Manager – Regulatory Affairs
IPCA Labs Vice President
Get Involved
Speaking Opportunities
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
Sponsor / Exhibit / Delegate Bookings
E-mail us at
bookings@virtueinsight.com
+91 44 42108101
