K. BANGARURAJAN CDSCO
RAJENDRA H. JANI Zydus Cadila
ARUN BHATT Consultant - Clinical Research & Development
VIVEK GUPTA Acceliant
KARIM DAMJI Saama Technologies
NAMRATA SINGH Turacoz Healthcare Solutions
SRIRUPA DAS Abbott
CHIRAG TRIVEDI Sanofi
EMRAN KHAN Cipla
YASHESH MEHTA Sciformix
NARESH TONDARE Glenmark Pharmaceuticals
ARUNKUMAR S Acceliant
MILIND ANTANI Nishith Desai Associates
MANISH VERMA Sanofi
PRASHANT BODHE CliniSearch
JYOTSNA PATWARDHAN Novartis
ASHWANI PANDITA Glenmark
AMEY MANE Johnson & Johnson
KAVYA KADAM (Former - Head - Global Clinical Operations, Cipla BioTec)
PRAVIN GHADGE Reliance Life Sciences
CHANDAN BADAPANDA Xcelris Labs
24th May 2017, Kohinoor Continental Hotel, Mumbai, India
“A critical guide for successfully conducting clinical trials”
- Conference Info
- Day One
- Sponsorship Opportunity
Virtue Insight’s 8th Annual Clinical Trials Summit will bring together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The 2017 program focuses on key issues and opportunities in the clinical trial industry, including Patient Recruitment, Site Selection, Data Integration, Existing Data Sources, Mobile Tech, Project Management, Outsourcing, Vendor Management, Risk-Based Monitoring, Clinical Auditing, Regulatory Authorities, pharmaceutical industries, contract research organizations, patient associations, and academic groups are represented. This conference is known to facilitate the interaction between all stakeholders, speakers and participants, thus encouraging lively Q&A sessions without cultural barriers. In addition, as usual, this Conference represents a great opportunity to network with all players involved in drug and device development.
The fast change of our working environment - be it regulatory or scientific - requires an accurate update for those with accumulated experience wanting to gain new competencies, but in particular also for the young stakeholders who will contribute to the development of the next generation of drugs and devices.
Virtue Insight also offers comprehensive sponsorship packages, which includes presentation opportunities, exhibit space, branding and networking with specific prospects. Sponsorship allows you to achieve your objectives before, during, and long after the event. Any sponsorship can be customized to meet your company’s needs and budget. Signing on early will allow you to maximize exposure to qualified decision-makers.
It gives us immense pleasure in welcoming you to the 8th Annual Clinical Trials Summit 2017. I wish and pray that all our efforts will be beneficial to our industries and to our country at large
KEY THEMES DISCUSSED:-
- Key drivers behind achieving a successful and sustainable clinical trails strategy in 2017
- Develop faster, more effective strategies by setting up big data with the power of sophisticated analytics
- Outsourcing early stage manufacturing
- Benefits and challenges with using local and international vendors
- Develop trial design and elaborate patient access
- Span all phases of clinical and observational research
- How we use mobile in clinical trials nowadays? What is the present barrier?
- Integrated approaches to using digital as a clinical Tool: Real world trials and population health in the east India
- The Impact of in-life unjust information on clinical trials execution
- Observing operational progress and efficiency of a study or an asset in critical for drug development success
- Strategic partnerships between Sponsor-CRO and how the industry has evolved in the past 5 years
- DATA – Collection, Design, Storage, Execute and Manage clinical trials - an architect’s perspective
- Possibilities for transforming data into quantifiable knowledge and growth in the quantity of clinical data collected
- Human factors trial design and management
- Understanding new e-clinical technologies to improve data quality and optimise clinical outcomes
- What are the expectations of regulatory authorities and what type of regulatory structure does India currently have?
- Updates on development for safety reporting in Indian clinical trial regulation
- Next generations of clinical trials – How big will the market be?
- Be part of a major networking opportunity
WHO SHOULD ATTEND:-
CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of:
- Clinical Research & Development
- Clinical Research Services
- Clinical Operations
- Clinical Data Management
- Clinical IT
- Clinical Trials
- Medical Affairs
- Regulatory Affairs
- Quality control / Assurance/GCP
- Clinical Study Design
- Safety Surveillance
- Subject Recruitment
- E-Clinical Systems
WHY SHOULD YOU ATTEND?
8th Annual Clinical Trials Summit 2017 - “A critical guide for successfully conducting clinical trials” - 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 drinks time, meet the leading international vendors expand your knowledge of the latest business models and strategies in the high-level conference. Show casing the products of tomorrow in the co-located exhibition.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Chairperson opening remarks
PRASHANT BODHE, Director, CliniSearch
MARKET OVERVIEW & ANALYSIS
09:30 – ICH GCP Integrated Addendum 2016 : Implications for India
- Amendment objectives
- Responsibilities of Sponsors – Quality management, Risk Based Monitoring,
- Responsibilities of Investigators
- Implications for India
ARUN BHATT, Consultant – Clinical Research & Development
10:10 – How next generation Technologies can help you take your product faster in market
VIVEK GUPTA, Worldwide VP, Acceliant
10:40 – Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
11:10 – Develop trial design and elaborate patient access
- Span all phases of clinical and observational research
- Expand and influence on physician therapeutic decisions
- Databases and clinical records, which can improve patient recruitment for clinical and observational research
- Patients with longitudinal clinical records, which can be used for real-world evidence studies that deliver clinical, financial, and humanistic outcomes
- Clinical trial environment where patient-specific clinical information can be easily transferred and shared within a payer system
- Improved patient access to coverage and reimbursement for new healthcare technologies
- Integrate value-focus across the product lifecycle
- Identify market trends that are causing a move to a value based reimbursement and decision model
- Explain the value of gaining payer input into clinical trial design
CHIRAG TRIVEDI, Director & Head of Clinical Study Unit, Sanofi
RAJENDRA JANI, Advisor/ Independent Subject Expert, Zydus Cadila
ARUNKUMAR S, Functional Lead, Acceliant
KAVYA KADAM, (Former - Head- Global Clinical Operations, Cipla BioTec)
NAMRATA SINGH, Founder and Director, Turacoz Healthcare Solutions
CHANDAN BADAPANDA, AGM-Bioinformatics, Xcelris Labs
SPONSOR – SITE- CRO – PATIENT
12:00 – Centralizing Data to Address Imperatives in Clinical Development
The clinical development data deluge is reaching critical mass for pharmaceuticals. Use of varied data for targeted outcomes remains difficult, despite studies that generate evidence of the risk-benefit profile of investigational products. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical operations and clinical science. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.
KARIM DAMJI, SVP - Products and Marketing, Saama Technologies
12:30 – Networking luncheon
Afternoon chair person
13:40 – DISCUSSION WITH EXPERTS: Strategic partnerships between Sponsor-CRO and how the industry has evolved in the past 5 years
- How is the partnership model trending? Are collaborating arrangements still increasing in number and/or scope, or is the model in decline? What are the key reasons behind current trends?
- How well do Sponsor and CRO expectations of these relationships align? Do we still see the gaps we observed in 2012? Have expectations increased or decreased due to the experiences of the past 5 years?
- Have partnerships delivered on the prospective benefits of enhancing R&D productivity and/or efficiency? What is preventing us from accelerating progress?
- To what extent do Sponsor/CRO relationships impact prevailing topics in clinical development such as enhanced patient engagement, leveraging big data, novel approaches to protocol design, and utilization of quality management systems?
- What does the future hold for Sponsor/Provider relationships? Do we expect measured, incremental change, or are there disruptive paradigms that could alter the landscape?
PRASHANT BODHE, Director, CliniSearch
EMRAN KHAN, Head-R&D Outsourcing Services Procurement, Cipla
ASHWANI PANDITA, Dy. General Manager Quality Management & Training, Global Clinical Research Operations, Glenmark
YASHESH MEHTA, Director Delivery Partner, Sciformix
AMEY MANE, General Manager- Medical Affairs, Johnson & Johnson
14:30 – “Observational studies and ethical considerations: When and where to take them?”
NAMRATA SINGH, Founder and Director, Turacoz Healthcare Solutions
15:00 – Afternoon Tea/Coffee
15:20 – Differentiated clinical trial designs for a branded generics portfolio
SRIRUPA DAS, Associate Director - Medical Affairs, Abbott
15:50 – DISCUSSION WITH EXPERTS: Clinical trial regulatory challenges
- Challenges faced by Sponsors and CROs
- Updates on development for safety reporting in Indian clinical trial regulation
- Overview of the regulation on risk-adapted trials and key factors
- IMA regulations and policies - how are patients and ethics committees impacted and do the regulations meet their needs?
- Regulatory challenges and constraints when evaluating vaccine clinical trials
- Present situations in the regulation of vaccines and how they are being addressed
- Improve patient safety, reporting timeliness of critical adverse events including deaths during clinical trials, and the payment of compensation to patients
- Trial design and applicable regulatory guidance strategies to overcome
- Regulatory considerations for a trial being run across different regions
MILIND ANTANI, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associates
K. BANGARURAJAN, Deputy Drugs Controller (India), CDSCO
SRIRUPA DAS, Associate Director - Medical Affairs, Abbott
NARESH TONDARE, Head– India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
JYOTSNA PATWARDHAN, Head Development QA, Novartis
MANISH VERMA, Head of Medical Affairs, CHC South Asia Zone, Sanofi
PRAVIN GHADGE, Head - Medical Writing & Pharmacovigilance, Reliance Life Sciences
16:50 – Chairperson’s closing remarks and end of conference
17:00 – 18:00 – Networking Drinks Session
Deputy Drugs Controller (India)
Dr. K. Bangarurajan did his Degree in Pharmacy from Madras Medical College and M. Pharmacy from Banaras Hindu University, Varanasi in the Year 1984 and was awarded Ph.D. by Tamil Nadu Dr. MGR Medical University in the Year 2000.
He began his career as a lecturer at J.S.S. College of Pharmacy, Ooty.
He joined the Drugs Control Department in the Year 1986 as a DRUGS INSPECTOR and served as a Senior Drugs Inspector and Assistant Director of Drugs Controller.
He was awarded as "Best Drugs Inspector" in the year 2005.
He joined the Central Drugs Standard Control Organization, Headquarters at New Delhi in the Year 2010 and since 24th February 2014, he is posted at Central Drugs Standard Control Organization, West Zone, Mumbai. He has the overall charge of the Western region and responsible for uniform implementation of the provisions of the Drugs & Cosmetics Act and rules thereunder.
He has made remarkable contributions in National and International seminars, workshops, which shows his urge for upgrading knowledge of the complex pharma spectrum which undergo rapid changes.
RAJENDRA H. JANI
Advisor/ Independent Subject Expert
- Presently Advisor to large pharmaceutical companies,
- Worked for large global Pharmaceutical companies,
- Unique blend of R&D management skills combined with business management experience,
- More than 37 years’ experience with healthcare system of government, global companies and also possess hardware, software and networking across the globe.
- Extensive experience in R&D system management as well as team building and negotiation. Able to motivate and move a group toward a consensus in the clinical research.
- As a member of senior management teams of pharmaceutical companies, extensive exposure also to strategies, medico-marketing, formulation development, manufacturing, etc.
- Detail oriented, strong analytical skills.
- Proven history of solving complex operational problems and getting success
Consultant - Clinical Research & Development
Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases.
Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited.
Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.
In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research.
Dr Bhatt is the recipient of Drug Information Association outstanding Service award 2012 for his immense contributions in his field of specialization.
Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013.
Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials.
Dr Bhatt has more than 100 publications in national and international journals. He runs a regular monthly column on “Good Clinical Practice – Question Answers” and has published a book “Clinical Trials and “Good Clinical Practice in India – Questions and Answers”.
Vivek Gupta is the worldwide VP at Acceliant. Vivek is an accomplished technology leader with demonstrated track record of driving sales organizations. At Acceliant, he is responsible for formulating sales strategy and implementing the execution plan. He focuses on increasing the existing market share and identifying new business development opportunities.
SVP - Products and Marketing
Karim is Senior VP, Product Management and Marketing, and joined Saama from Plantronics, where he led software strategy and product management, focusing on driving developer platforms, strategic partner integrations and contextually enabled UC solutions.
Prior to joining Plantronics, Karim served in leadership positions spanning business development, product management, sales and network engineering at Cisco, Vocera Communications, MobileIron and DiVitas. Karim spent 7 years at Cisco building global VoIP and WAN networks, eventually transitioning to product architecture positions. At Vocera Communications, Karim was the founding product manager responsible for driving product concept to market-leading solutions.
Founder and Director
Turacoz Healthcare Solutions
An experienced pediatrician with intuitive and comprehensive medical communicating skills. Being on both sides of the table- pharmaceutical/biotech and healthcare professionals/hospitals, Namrata understands and comprehends the requirement and delivers spot on. Her forte initiates from being a part of the initial planning to delivering the final customized solutions. She has experience and expertise across all major medical documents (publication, regulatory and marketing) and all major therapeutics areas. As an entrepreneur and trainer, she is always ready to explore new ideas and opportunities which will impact the way scientific evidence is communicated. Turacoz Skill Development Program, a wing of Turacoz Healthcare Solutions, takes initiatives to full fil the gap between the academic curriculum and the industry requirements and have customized and specialized training solutions in the form of seminars, workshops, and e-learning modules for healthcare and pharmaceutical professional, pharmacy students, researchers and scholars.
Associate Director - Medical Affairs
Dr Srirupa Das has done her MD in Pharmacology from VSS Medical College, Burla and has a Post Graduate Diploma in Marketing Management from NMIMS, Mumbai. She started her career in the pharmaceutical industry in the year 2003 in Fresenius Kabi. Successively, she has had stints at Lupin Research Park and Sun Pharma Advanced Research Company before joining Abbott India Limited in 2011. Currently she is employed as Associate Medical Director-Medical Affairs responsible for Medical Affairs and governance for Abbott Primary Care.
Director & Head of Clinical Study Unit
Chirag Trivedi is currently working in Sanofi as Director and Head of Clinical Study Unit (CSU) in India. The CSU manages the Clinical trials (for R&D and marketed Products) from Phase II-IV, Observational studies and Bioequivalence studies. It also plays a strategic and operational role in the Life Cycle Management of products.
He has been with Sanofi since May 2006 and has handled various roles and responsibilities in these years. Prior to Sanofi, he has worked in a CRO and prior to that, in a Central Lab.
He is a Ph.D. in Pharmacology from Mumbai University and is experienced in the fields of Clinical Research, Clinical Quality Assurance & Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development.
Head-R&D Outsourcing Services Procurement
Director Delivery Partner
Head - India and Nepal Regulatory Affairs
Dr. Naresh Tondare is a Regulatory Expert with 11 years of experience in the areas of Regulatory Affairs/strategy, Product/Formulation Development, New Drug Delivery/Technologies and Clinical Research.
He has completed a post graduate degree (MD) in Ayurvedic/Herbal Pharmacology and Pharmaceutical from Govt. Ayurvedic Medical College in 2004. He has also completed a PGDIM from School of Management Studies (SOMS), New Delhi in 2009 and a Black Belt in Six Sigma (BBSS) programme from Indian Statistical Institute (ISI) in 2008.
Currently, he is working with Glenmark Pharmaceuticals Ltd, Mumbai as a Head- India and Nepal Regulatory Affairs (Senior Manager) since 2011. He is responsible and accountable for regulatory strategy and regulatory submissions of New Drug, NCE, Subsequent New Drug, OTC, Food Supplements, Herbal Products and Cosmetics for India and Nepal Region. Prior to Glenmark, he has worked with several organizations such as AccuMED, SmartAnalyst etc.
Arun has 13+ yrs of experience in Clinical Research Industry and predominantly spent most of tenure in CDM space.
A certified clinical data manager and having work with companies like Novartis and Jubilant Clinsys before Acceliant. At Acceliant, Arun Plays a critical role in functional assignments to understand Industry needs and act as a bridge between Domain and Technology delivery.
Partner In-Charge - Pharma LifeSciences
Nishith Desai Associates
Dr. Milind Antani is a Partner in charge 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.
Head of Medical Affairs, CHC South Asia Zone
Dr Verma completed his MD in internal medicine from Gandhi Medical College, Bhopal. From 2005 to 2013, he has held several positions in medical affairs, clinical research and pharmacovigilance at Eli Lilly, Ranbaxy and Biocon. Dr Verma joined Sanofi India Limited as Director Medical Affairs for Cardiovascular Thrombosis, Internal Medicine and Hospitals in September 2013. Sanofi is a global truly diversified healthcare leader present in India since 1956. Dr Verma has published over 10 abstracts/papers in national/international journals of high repute and has been invited speakers/panelist at several national/international conferences for presenting his work. His focus area of work has been new drug development, patient support programs, public health initiatives and clinical research in the field of non-communicable disease mainly, diabetes, hypertension, dyslipidemia and cardiovascular diseases. He served as scientific committee member for the countries first ever white paper for strengthening policies on diabetes care.
Pharmacologist with 24+ years of experience in Regulatory Affairs; Quality Compliance and Systems; Global Clinical Research (Phase I-III) & Pharmacovigilance; API, Toxicology; Formulation Development; Bioavailability, Bioequivalence Studies, Pharmacokinetics
CliniSearch; Proprietor; Consultant, Pharmaceutical Research and Development
June 2014 - Present
Director of Operations, Medanta Duke Research Institute (MDRI)
Medanta The Medicity Sector 38, Gurgaon, Haryana, 122001, India; Aug 2013 – June 2014
Associate Director, Clinical Operations & Office Head, Sri Lanka Quintiles Research (India) Pvt. Ltd.; Feb 2011 – June 2012
Director, Clinical Development Center
Advance Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Center, Navi Mumbai; Jan 2008 - May 2010
CliniSearch Biotechnologies, Navi Mumbai, India; Dec 2003 - Dec 2007
Deputy General Manager (Senior Clinical Pharmacologist) Lupin Research Park, Pune, India; Dec 2002 - Dec 2003
Head Regulatory Affairs (India Region) Cipla Ltd., Mumbai, India; Jul 2000 - Dec 2002
Assistant Manager, Department of Pharmacology, Toxicology, Research and Development
Cadila Pharmaceuticals Ltd., Ahmedabad, India; Since Dec. 1998 to Jul. 2000
Senior Research Fellow
Liposome Clinical Pharmacology Center, Dept. of Clinical Pharmacology, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, India; Nov. 1991 - Dec. 1998
Indian Institute of Toxicology, Pune, India; Apr. 1988 - Oct. 1991
- Life member of ACTREC Alumni Association, Tata Memorial Center, Kharghar, India
- Indian Pharmaceutical Association (Life Member)
- Registered Pharmacist (Life)
- 13 scientific papers in indexed International (4) and National publications (9)
- Presentations: http://www.slideshare.net/PrashantBodhe
Head Development QA
Pharma professional holding Masters degree in Pharmaceutical Sciences and post graduate diploma in clinical research. Have experience of over two decades in the Indian pharmaceutical industry across different verticals like formulation development, regulatory affairs, Clinical Operations, pharmacovigilance, quality and compliance
Currently working as Head Development QA and responsible to implement and maintain the local Quality System in the areas of GCP and GPvP at Novartis
Have experience in hosting as well as auditing Pharmacogilance as well as clinical trial activities including sites, vendors CROs etc. Hosted USFDA inspection Driven various Initiatives to create awareness about compliance and GxP concepts. Actively driving the initiatives to create Quality Culture within organization
Dy. General Manager Quality Management & Training, Global Clinical Research Operations
Ashwani Pandita is associated with the clinical research industry in India for more than 14 years. He has worked at various levels in the CRO space as well as in the sponsor companies.
Ashwani is a pharmacist by education. He has studied pharmacy at Nagpur University and also has a Master’s in Quality Management from BITS Pilani in India.
Ashwani has also earned the credentials of Registered Quality Assurance Professional in GCP from the Society of Quality Assurance, USA.
Currently, Ashwani is associated with Glenmark Pharmaceuticals Limited in India, as Dy. General Manager and Head of Clinical Quality Management & Training.
General Manager - Medical Affairs
Johnson & Johnson
Amey Mane is currently General Manager-Medical Affairs at Janssen India(Pharmaceutical companies of Johnson & Johnson). He is a clinical pharmacologist with 14 years of experience in multinational and Indian pharma.He has handled diverse responsibilities in medical affairs,clinical research, medical writing and pharmacovigilance. He has >10 international publications in diabetes,vaccine, pharmacovigilance, epidemiology and clinical research domains.
Janssen (Pharmaceutical companies of Johnson & Johnson) - (October 2014-Present) General Manager-Medical Affairs
Wockhardt Ltd.(October 2012- October 2014) DGM-Medical Affairs
Reliance Clinical Research Services (September 2011- October 2012) Head Medical writing & Pharmacovigilance
UCB India Ltd (December 2008-September 2011) Medical Advisor (Neurology) (June 2009-September 2011)
Panacea Biotec Ltd. (October 2007-December 2008)
Clinical Pharmacologist(December 2008-June 2009)
Clinical Research Manager Wockhardt Ltd. (August 2006- October 2007)
Lambda therapeutics (July 2004-July 2006) - Clinical Pharmacologist
• MD (Pharmacology) ;Mumbai University- 2006
• MBBS ;Mumbai University- 2001
(Former - Head - Global Clinical Operations, Cipla BioTec)
Dr. Kavya Kadam heads Global Clinical Operations at Cipla BioTec with 15+ years of experience including CRO, Biopharmaceutical industries and Clinical Practice. She is a medical graduate from Seth G. S. Medical College, Mumbai and is presently pursuing an Executive MBA from SP Jain Global School of Management, Mumbai.
In her current profile, Dr. Kavya Kadam is responsible for Clinical Operations and Clinical Trials, globally. In her short tenure since December 2015, Dr. Kavya Kadam has already initiated the first Human trial for Cipla BioTec.
Dr. Kavya Kadam has managed Global Clinical Trials and Clinical Operations for International Clients. While doing so, she has had hands-on-experience of managing trials in various therapeutic areas including biosimilars, generics, monoclonal antibodies, stem cell, vaccine, proof-of-concept trials to name a few.
During her earlier years, Dr. Kavya Kadam has managed end to end Regulatory and Project Management in the Asia-Pac region. She also worked in the early development set-up as a Principal Investigator for early development studies including Phase I, Phase II and B.A.B.E. studies.
Head - Medical Writing & Pharmacovigilance
Reliance Life Sciences
“Acceliant provides real time, integrated clinical trial solutions for life sciences, CROs and pharma tools and expertise to take intelligent and smarter decisions. Its eClinical Suite allows users to build studies, design electronic case report forms (eCRFs), capture data through multiple sources (EDC), capture data directly from patients (ePRO), and manage other clinical data management functions.”
Saama Technologies is the first advanced hybrid analytics company delivering actionable business insights for life sciences, and the Global 2000. We are singularly focused on driving fast, flexible, impactful business outcomes for our clients through data & analytics. Our unique “hybrid” approach integrates focused solutions and expertise across the life sciences domain, business consulting, data science, automated data management and big data technologies. We blend manual and disconnected initiatives into a well-aligned roadmap facilitating the client’s journey from strategy through solution implementation.
Nishith Desai Associates
Nishith Desai Associates (NDA) is a research based international law firm with offices in Mumbai, Bangalore, Palo Alto (Silicon Valley), Singapore, New Delhi, Munich and New York. We provide strategic legal, regulatory, and tax advice coupled with industry expertise in an integrated manner.
As a firm of specialists, we work with select clients in select verticals. We focus on niche areas in which we provide high expertise, strategic value and are invariably involved in select, very complex, innovative transactions.
We specialize in Globalization, International Tax, Fund Formation, Corporate & M&A, Private Equity & Venture Capital, Intellectual Property, International Litigation and Dispute Resolution; Employment and HR, Intellectual Property, International Commercial Law and Private Client. Our industry expertise spans Automobile, Funds, Financial Services, IT and Telecom, Pharma and Healthcare, Media and Entertainment, Real Estate, Infrastructure and Education. Our key clientele comprise marquee Fortune 500 corporations.
Equally passionate about philanthropy and the social sector, our forte includes innovation and strategic advice in futuristic areas of law such as those relating to Bitcoins (block chain), Internet of Things (IOT), Privatization of Outer Space, Drones, Robotics, Virtual Reality, Med-Tech and Medical Devices and Nanotechnology.
Nishith Desai Associates is ranked the ‘Most Innovative Asia Pacific Law Firm in 2016’ by the Financial Times - RSG Consulting Group in its prestigious FT Innovative Lawyers Asia-Pacific 2016 Awards. With a highest-ever total score in these awards, the firm also won Asia Pacific’s best ‘Innovation in Finance Law’, and topped the rankings for the ‘Business of Law’. While this recognition marks NDA’s ingress as an innovator among the globe’s best law firms, NDA has previously won the award for ‘Most Innovative Indian Law Firm’ for two consecutive years in 2014 and 2015, in these elite Financial Times Innovation rankings.
Our firm has received much acclaim for its achievements and prowess, through the years. Some include:
IDEX Legal Awards: In 2015, Nishith Desai Associates won the “M&A Deal of the year”, “Best Dispute Management lawyer”, “Best Use of Innovation and Technology in a law firm” and “Best Dispute Management Firm”. IDEX Legal recognized Nishith Desai as the Managing Partner of the Year in 2014.
Merger Market has recognized Nishith Desai Associates as the fastest growing M&A law firm in India for the year 2015.
World Tax 2015 (International Tax Review’s Directory) recognized NDA as a Recommended Tax Firm in India
Legal 500 has ranked us in tier 1 for Investment Funds, Tax and Technology-Media-Telecom (TMT) practices (2011, 2012, 2013, 2014).
International Financial Law Review (a Euromoney publication) in its IFLR1000 has placed Nishith Desai Associates in Tier 1 for Private Equity (2014). For three consecutive years, IFLR recognized us as the Indian “Firm of the Year” (2010-2013) for our Technology - Media - Telecom (TMT) practice.
Chambers and Partners has ranked us # 1 for Tax and Technology-Media-Telecom (2015 & 2014); #1 in Employment Law (2015); # 1 in Tax, TMT and Private Equity (2013); and # 1 for Tax, TMT and Real Estate – FDI (2011).
India Business Law Journal (IBLJ) has awarded Nishith Desai Associates for Private Equity, Structured Finance & Securitization, TMT, and Taxation in 2015 & 2014; for Employment Law in 2015
Legal Era recognized Nishith Desai Associates as the Best Tax Law Firm of the Year (2013).
ASIAN-MENA COUNSEL named us In-house Community ‘Firm of the Year’ in India for Life Sciences Practice (2012); for International Arbitration (2011); for Private Equity and Taxation in India (2009). We have received honorable mentions in ASIAN-MENA COUNSEL Magazine for Alternative Investment Funds, Antitrust/Competition, Corporate and M&A, TMT, International Arbitration, Real Estate and Taxation and being Most Responsive Domestic Firm.
We have won the prestigious ‘Asian-Counsel’s Socially Responsible Deals of the Year 2009’ by Pacific Business Press.
We believe strongly in constant knowledge expansion and have developed dynamic Knowledge Management (‘KM’) and Continuing Education (‘CE’) programs, conducted both in-house and for select invitees. KM and CE programs cover key events, global and national trends as they unfold and examine case studies, debate and analyze emerging legal, regulatory and tax issues, serving as an effective forum for cross pollination of ideas. Our trust-based, non-hierarchical, democratically managed organization that leverages research and knowledge to deliver premium services, high value, and a unique employer proposition has been developed into a global case study and published by John Wiley & Sons, USA in a feature titled ‘Management by Trust in a Democratic Enterprise: A Law Firm Shapes Organizational Behavior to Create Competitive Advantage’ in the September 2009 issue of Global Business and Organizational Excellence (GBOE).
© Nishith Desai Associates 2016
GNH India - A Global Full line Pharmaceutical Wholesalers with over 135,000 Product lines, supplying to over 180 countries World wide.
Specialising in Clinical Trial Supplies, Comparator supplies, Rescue Medication, Adjuvant therapeutics, Shortages, Hard to find lines, Hospital lines and Named Patient lines.
Operating from a WHO cGDP compliant warehouse with a well trained staff, under supervision of an on site QP.
Key advantages when working with GNH India:
1. Complete, audit-able paper trail to manufacturer
2. Shortest Pedigree to manufacturers
3. 21 CFR part 11 compliant Temperature monitoring and inventory management softwares
4. Validated Shipping systems
5. Counterfeit and fake prevention systems in place to maintain supply chain integrity
6. Instant availability of most drugs, including hard to find and name patient lines
Partner with a team of Pharma industry professional, partner with GNH India for all your requirements from India.
Clinion is a clinical trial solution, which is uniquely focused on delivering superior user experience. Its advanced Electronic Data Capture (EDC) features help streamline the entire Clinical study process starting from study design all the way to data capture, medical coding and data management. Clinion provides a fully featured, 21 CFR part 11 compliant EDC solution, giving both investigators and monitors a powerful yet easy-to-use environment for data entry and monitoring. Clinion supports all the steps of the clinical trial process from translation of the clinical trial protocol to the consolidation of all collected trial data, ready for reporting and analysis. It is available online and can be securely accessed from anywhere by authorized users.
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.
LEX WITNESS – India’s 1st Magazine on Legal & Corporate Affairs
LEX WITNESS vows to be a high quality monthly magazine with the powers of fresh and original content that would deal exclusively with subjects pertaining to legality. Country's top notch practitioners and experts are being invited to contribute in WITNESS with what we feel is relevant to all stakeholders in this profession, aiming at brainstorming between the legal luminaries and hence bettering this practice in all its aspects.
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Bookmytrainings.com is India’s leading training marketplace offering classroom, online, e-learning & in-house training to corporate & working professionals.
More than 1000 unique courses are available including on the latest technologies like Cloud, Big data, Agile, DevOps & IoT.
Benefits to Individuals:
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• Bring in the right expert for any training requirement – technical, functional or behavioural
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Clocate.com is a leading international directory for worldwide conferences and exhibitions. Clocate.com is equipped with a unique and comprehensive search that helps you find easily any event in any category or location. Each event includes detailed information, like, description, dates, location, map, prices, link to the official event's website and more...
If you search for a conference or exhibition in areas such as Industry and manufacturing, Health and medicine, Technology and IT, Business and finance, sciences, education, services (banking, insurance, tourism, Hospitality and more), government, environment, life style and arts, you'll find it in Clocate.com.
MEDGENERA is a leading integrated digital media and marketing platform for biotech, pharma and chemistry Industries. Join them (for free!) and stay updated for the entire perspectives on entrepreneurship, investment and true innovations in these industries.
Life Science World
LSW LifeScienceWorld is an Online Magazine on Pharma & Biotech industry which has eminent scientists, Researchers, Industry professionals as Advisory Board Member actively involved on regular basis.
• Articles/Features on subjects not heard of, but of utmost importance in the
industry.Interviews with eminent personalities on subjects not dealt before.
• Guest Desk: Columns/articles by Professionals
• Individual sections on Pharma, Biotech, Technology and Life Science
LSW Forum: Objective
Take up issues concerning the industry to government agencies like DCGI, ICMR, DBT, Dept. of Pharmaceuticals and the Ministry of Health & Family Welfare by way of organising Roundtables between Industry personnel and Regulatory officials periodically.
JSB Conference work’s globally for crafting your proposal at international level, by giving a surety that delegates land up meeting a right audience, to show-off their business skills. Embark your journey by meeting Leading Enterpernure, Bussiness tycoon, Banking & finance Leaders and Growing start-ups.
The conference is "All ABOUT TOGETHERNESS" and we "UNIT AS JSB CONFERENCE".
Website URL :
BioChem Adda aims to provide the most reliable information portal related to Biotech Jobs, Biotech Internships in the USA, Biotech Internships in India, Biotech Companies Database, Careers, Education, Fellowships, News, Articles, and Events from the field of Biological and Chemical Sciences!
Partnering with Virtue Insight means more than making the right contacts. It means being an insider. It means being connected to the right people with the right level of influence, and it means you are allied with a globally respected organization and leaders in the industry.?
Sponsorship, exhibiting and advertising packages are designed to provide a solid platform to help you stand out and make an impact. Our programs allow you to achieve your marketing goals and deliver a maximum return on your investment. We have developed convenient and customizable packages to help your organization meet its objectives and reach your target market.
Why Sponsor / Exhibit:
MARKET SHARE: Defending and Increasing Market Share
COMPETITION: To attach and defend against competition
- Generating sales leads
- Build brand image
- Maintaining customer relations
- Consolidating business relationships
- Accessing new and emerging markets
- Obtaining technical knowledge
- Leverages the events extensive marketing campaign to add value to your organisations marketing strategy and budget leading up to the event
- Live product demonstration to test market responses
- Facilitating quick market penetration
- Reach important targeted commercial prospects face to face in a social, relaxed environment. The ideal platform to build strong business friendships Strengthen your market position
Our conferences offer not only a unique combination of benefits (as listed above) to enable the sponsor/exhibitor to communicate the message but also a major opportunity that other forms of selling or media cannot provide.
Contact Us Today
Email - firstname.lastname@example.org
Email - email@example.com
Tel: +91 44 64536444
Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.
What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.
What are the benefits of attending?
- Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
- Enjoy our informal networking at drinks and lunch
- Meet the leading solution providers in the market to forge partnerships and discover solutions
- Receive electronic versions of the conference documentation for use of reference post-event.
- Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
- Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
- Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
- Delegates also benefit from discounted rates onfuture event attendance
For more information or to register at the event please contact us TODAY:
Contact Us Today
Email - firstname.lastname@example.org
Email - email@example.com
Tel: +91 44 64536444
Standard Price – 1 or 2 Delegates - (INR 8,000 + Tax (15%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – firstname.lastname@example.org
Group Discounts – 3 or 4 Delegates - (INR 7,000 + Tax (15%) per delegate)
Group Discounts – 5 and above Delegates - (INR 6,000 + Tax (15%) per delegate)
Spot Registration on the day of the Conference – 1 Day Conference - (INR 9,000 + Tax (15%) per delegate)
Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL: + 91 44 64536444. Email - email@example.com
Kohinoor Continental Hotel
Address: Andheri Kurla Road, Andheri ( E ), Mumbai 400059 - India
Phone: 91 22 66919000 / 91 22 28209999
Testimonials from our past Clinical Trials Summit Conferences
Great networking event – Business Enablement & Strategy, Saama Technologies
Nice and arranged and organised well – Vice President, Mascot Spincontrol
Very well structured summit. Adequate knowledge on the topic of clinical research, regulations, guidelines, amendments, etc are well discussed – ICRI (Institute of Clinical Research, India)
Conference was very informative and the positive of the conference is Mr. Bangarurajan sir. Regulatory perspectives were very much good and clarified. Very much happy for the conference – Research Associate, The Himalaya Drug Company
Very informative. Good refresher on latest guidelines. Good conference for networking – Co-ordinator, CDSA-CCRE
Over all good - Safety physician, Sciformix
It was good & interadity sessions - Quality lead, PV, Sciformix Tech pvt.ltd
1. Very useful to network with sponsors and CRO. 2. Good place to know the progress of competition - Manager - eclinical, DDi
Great conference for networking and relationship - Officer, Spilcsun Pharma
It was great experience attending this clinical trial summit 2015. It Learned lot of new updates in clinical trial industry as well as regulatory - Sr. Manager Clinical Research, OmniActive Health Technologies
Since Pharama companies have ventured into Biologicals/ Biosimilars business, the conference could have focused on discussing case stdies in Biosimilars Clinical trails, challenges in CTS in New Biologicals& Vaccines - Regulatory Affairs Biologicals-Cipla New Ventures, Cipla
Very interactive informative and time managed session - Manager - QA &RA, Sanofi Pasteur
The sessions was informative on products and the discussions was fantastic. It has given a better idea on where the industry is heading. To start a new era of clinical trials, this seems to be a promising start for the industry. The second innings for the clinical trials seems promising technically as well as operationally - Senior Business Analyst, HCL Technologies
Well Organized - Team Leader, Lotus Labs
This conference was informative. There was good exchange of information. It provided current and actual seminar in india regarding Clinical Trials would like to attend this conference in future - Clinical Research Associate, Lambda Therapeutic Research
Many presentations covered were eye openers and being from a typical IT Service provider company, the conference really added value in terms of clarifying the business processer and challenges of Pharma industrials - Associate Business Manager, HCL Technologies Ltd
Topic was very good huge on current seminar, Location is very good to Aelequase, Speaking was good to deliver current situation, Very on panel discussion and due and Answer session - Sr. CRA, Lambda Therapeutic Research
“Fen and his team from Virtue insight have done a great job in bringing everyone together to share their ideas and experiences for clinical research industry in India- the past, present and future. It was nice meeting old contacts again as well as making some new ones at the event. I wish all the very best to the scientific mind and organizing execution committee for making this conference successful with all its share of challenges.” - Senior Medical Writer-Medical Writing, SIRO Clinpharm
Over all good experience and well conducted - Manager Clinical Ops, Dr. Reddy's Laboratories
Summit was well organized and very interesting panel of discussion - Business Development Manager, Clinical Research, Metropolis Healthcare
Great administration of entire programme session by session, pleasant surprise is that 95% of speakers as planned turned up - Director Operations, GSS HR Solutions
Excellent Organisation and facilities - Sr. CRA, GlaxoSmithKline
Conference was informative, a great opportunity to converse and interact with esteemed and prominent delegates and speakers from renowned organisations. Being a trainee it helped me out in understanding CR industry diversely and scenario globally - Trainee CRC, Trisha Trauma Centre
This is a really well managed, informative, interactive and learning event also allowing us to network together and its absolute a value for money. I wish them the “All is The Best”. Keep up the “GOOD SHOW” - Jatin Dhulla, General Manager, Accutest Research
Very Insightful.... - CEO, EOS Medical Research
Very good forum to network and an overall good set of information shared with the attendees - Project Executive, SRL
Its a good conference and the approach of new ideas get a merge in single pool without any barriers - Research Associate, Lupin Bioresearch Center
This conference gave a good insight of current challenges in running clinical trials in india – relating to regulatory, investigators, sites, training etc.... - Business development, Karmic Life sciences
Conference pictures can be viewed and downloaded at our official Virtue Insight facebook page
Link - Click Here