10th Annual Clinical Trials Summit 2019
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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.
Event Speakers
RUBINA BOSE
CDSCO (WZ)
AMITA BHAVE
Novartis
AMITA BHAVE
Novartis
AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis
• Amita Bhave, is Heading Regulatory Affairs, GDD India and is working with Novartis for more than 10 years. She had earlier handled added responsibility as head RA BoE in Hyderabad serving AMAC/ LACan countries.
• Amita has overall 20+ years’ experience in Indian Pharma industry earlier in multiple domains of Medical support, Clinical Operations, Regulatory Affairs.
• Amita has a huge experience of handling New drug applications, Import registrations, clinical trial applications and regulatory compliance and is instrumental is designing regulatory strategy for Novartis pipeline products.
• Amita is well connected in Indian pharma industry and Indian regulators’ office. She is an active member of Associations like OPPI in Medical- regulatory committee and was co-chair of ISCR regulatory council. She is also regular contributor as author to a peer reviewed journals and has various publications in well reputed journals. Amita has been guest invitee as speaker/ panelists in Industry forums.
• Amita has been honorary faculty at NMIMS University, Mumbai. She delivers guess lectures on Regulatory Affairs subject for curriculum of Executive MBA in Pharma Management.
OMPRAKASH S.S
FDA (Maharashtra state)
OMPRAKASH S.S
FDA (Maharashtra state)
OMPRAKASH S. SADHWANI, Former Joint Commissioner and Controlling Authority, FDA (Maharashtra state)
AMMAR RAZA
Allergan
PRAVIN GHADGE
Reliance Life Sciences
PRAVIN GHADGE
Reliance Life Sciences
PRAVIN GHADGE, Head of Clinical Research Services, Reliance Life Sciences
PRITI THAKOR
Johnson & Johnson
MOHAMMED S K
Quartesian
S.R.SALUNKHE
FDA Maharashtra
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Director, CLINEXEL Life Sciences
• 25-year experience in Pharma industry, academia and patient care.
• Experience in Pharmacovigilance, Clinical Development, Clinical Operations, Medical Information, preclinical studies and patient care.
• Set-up and successfully led efficient and regulatory compliant Global Pharmacovigilance function for two midsize companies.
• As the most responsible person of Pharmacovigilance, successfully faced PV inspections from different regulatory authorities without any critical or major findings
• Participated in various regulatory meetings, including pre-submission meetings with rapporteurs and co-rapporteurs to discuss the risk management plan, requirements of post marketing studies and other commitments as marketing authorization holder
• Interacted with various regulatory authority (MHRA, FDA, EMA, INFARMED, Health Canada, TGA) regarding clinical development path, drug safety assessment and risk management of biosimilars and other products
• Key member for clinical development and safety management of biosimilars. Worked in the clinical development of biosimilar insulins, GCSF and Etanercept.
• While working in Lupin, I successfully led Trimetazidine consortium of leading generic companies including Teva, Sandoz, Alvogen, Mylan, Generis and Gedeon Richter in Europe to conduct post authorization clinical studies imposed as a condition of marketing authorization for Trimetazidine. I did Project Management of these studies and after successfully completing these studies, published the results of these studies in peer reviewed journals.
• Experience of successfully driving public-private partnership with multiple stakeholders. Led the preparation of “Guidelines for the management of ADRs with anti-tubercular drugs” in collaboration with ICMR, CTB division and KOLs. These were released in 2016 for South East Asia
• Engaged with Indian authorities (PvPI) in drafting pharmacovigilance guidelines for India, designing the curriculum of pharmacovigilance training initiatives of PvPI
• Faculty and speaker at various international forums for PV and Clinical Research
• Author of the book written on industry practices in Pharmacovigilance “Pharmacovigilance- An Industry Perspective”
• Subject Matter Expert- Well versed with latest regulations and inspection trends in Pharmacovigilance globally
ROSHAN PAWAR
Alkem Laboratories
SOUGAT SARKAR
ELC group
KAMLESH PATEL
Insignia Communication
KAMLESH PATEL
Insignia Communication
KAMLESH PATEL, Director - Strategy, Insignia Communication & Founder -, Synaegis Healthcare
PRASHANT B
CliniSearch
PRASHANT B
CliniSearch
PRASHANT BODHE, Director, CliniSearch
Profile Description:
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
Professional Experience
Director
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
Vice President
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
Research Fellow
Indian Institute of Toxicology, Pune, India; Apr. 1988 - Oct. 1991
Professional Memberships
- Life member of ACTREC Alumni Association, Tata Memorial Center, Kharghar, India
- Indian Pharmaceutical Association (Life Member)
- Registered Pharmacist (Life)
Publications
- 13 scientific papers in indexed International (4) and National publications (9)
- Presentations: http://www.slideshare.net/PrashantBodhe
“A critical guide for successfully conducting clinical trials”
Event 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.
09:30 – Chairperson opening remarks
RANJIT BARSHIKAR, QbD / CGMP Consulting, Member Editorial Board Journal of Generic Medicines, England
MARKET OVERVIEW & ANALYSIS
09:40 – Reporting of serious breaches of GCP and protocol in the clinical trials
• Understand relevant regulations and guidelines
• Clarify the roles and responsibilities of different stakeholders
• Timelines and format for reporting of serious breaches
• Examples and case studies
DEEPA ARORA, Director, CLINEXEL Life Sciences
10:20 – Accomplish effective patient recruitment and retention in clinical trials by impacting innovations & digitisation in clinical research
• Bettering the grade of the international health clinical research
• Integrating innovations into clinical trials
• Is the consumer technology aspect in the head of innovation in clinical trials?
• Influence of clinical trials from trial design and data capture to community outreach and patient recruitment
PRITI THAKOR, General Medical Affairs Manager, Johnson & Johnson
10:50 – Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
11:10 – DISCUSSION WITH EXPERTS: Leveraging new technologies to improve clinical trials efficiency in Asia
• Transforming your trials procedure by implementing artificial intelligence
• Addressing the methods which will have the most impact on trials in five years, adaptive trials and risk-based strategies
• Giving an opportunity to render transformation in clinical trial methodology
• Discussing on using advanced analytics to monitor patients in their own home outside of the hospital environment
• View point from an industry: The future of investing technology in clinical trials. An overview at the impact of data collection and analysis methods, current challenges, and patient centricity.
• Being certain that FDA filing is successful and the drug or treatment in query is approved for mass distribution
• Key considerations for achieving digital trial success
Moderator
PRASHANT BODHE, Director, CliniSearch
Panellists
PRAVIN GHADGE, Head of Clinical Research Services, Reliance Life Sciences
KAMLESH PATEL, Director - Strategy, Insignia Communication & Founder - Synaegis Healthcare
DEEPA ARORA, Director, CLINEXEL Life Sciences
BINA NAIK, Chief Operating Officer, CBCC Global Research
MOHAMMED SALEEM KHAN, Manager Risk Based Monitoring, Quartesian
PRITI THAKOR, General Medical Affairs Manager, Johnson & Johnson
12:00 – DISCUSSION WITH EXPERTS: Investigating how trial sponsors and service providers can cooperate to better carry out the trial timelines while sustaining quality
• Why pharma and biotech industries are specified for new and smarter ways to conduct clinical research
• Initiating what the quality ‘touch points’ should be for the continuance of the trial so you can measure the success of your partnership
• Questioning what tools can be used to determine quality throughout the trial to assure you have an precise picture of how the service provider is acting on key deliverables
• Addressing best practices for developing well - defined SOPs to ensure service providers are better equipped to accomplish the clinical trial to a high standard
• Building progressive training schemes for service providers to be certain that information is reaching all employees undiluted
• Highlighting the requirement to have a grooming strategy in place to assure data quality is maintained at every stage
Moderator
RANJIT BARSHIKAR, QbD / CGMP Consulting, Member Editorial Board Journal of Generic Medicines, England
Panellists
PRASHANT BODHE, Director, CliniSearch
ROSHAN PAWAR, Senior Medical Advisor, Alkem Laboratories
ASHWANI PANDITA, General Manager Quality Management & Training, Global Clinical Research Operations, Glenmark Pharmaceuticals
RENUKA NEOGI, Clinical Research Operations Manager, Sanofi-aventis
SOUGAT SARKAR, General Manager- Clinical development, ELC group
12:40 - Networking luncheon
Afternoon Chair Person
S.R.SALUNKHE, Former Assistant commissioner, FDA Maharashtra
13:50 – Patient Centricity in Clinical Trials
• Role of patients in CTs … going beyond the current paradigm
• What does patient centricity mean?
• Why do we need patient centricity in CTs?
• Evolution of patient centricity
• Challenges and regulatory issues in a patient centric approach
• Global status & some examples of putting patient centricity in practice
AMMAR RAZA, Country Medical Director & Chief Medical Office, Allergan
14:20 – DISCUSSION WITH EXPERTS: Developing risk-based monitoring implementation: Deduction in technology, Role progress and Business process
• Concentrating on the lessons learned and best practices resulting from 5 years of RBM implementation
• Partnership between business and technology - Illustrating how innovation in one area causes the other
• Discussing CRA role including the development of new skill sets to address the evolved expectations, and the creation of new roles to support RBM
• Implications for implementation – Suggestion from sites about RBM, as well as audit results
• Discussing critical thinking — the need for people to have the skills to be able to assess the information they are seeing in doing centralized monitoring
• An adaptive approach that interact both on-site and centralized monitoring along with real-time access to data
Moderator
VAIBHAV SALVI, Head - Project Management and Strategic Initiatives, Sanofi
Panellists
RAVI SEKHAR KASIBHATTA, Senior Vice President, Clinical Research, Lupin
AMMAR RAZA, Country Medical Director & Chief Medical Office, Allergan
JYOTSNA PATWARDHAN, Head Development QA, Novartis
SAKHARAM GARALE, Head South-East Asia Operations ACMA
15:00 – Afternoon Tea/Coffee
REGULATORY
15:30 - Overview of the New Drugs and Clinical Trial Rules 2019
RUBINA BOSE, Deputy Drugs Controller(India), CDSCO (WZ)
16:10 – DISCUSSION WITH EXPERTS: Understanding the current framework of clinical trial regulations in India
• New Drugs and Clinical Trial Rules, 2019
• Understand the current framework of clinical trial regulations in India
• Brief information for preparing for regulatory inspection
• Improving the quality and lifespan of patients - The value of drug trials in promoting health services, new drugs and therapies
• Recently adapted regulatory guidelines in terms of serious adverse events (SAEs) reporting, informed consent, compensation in case of injury or death in clinical trials.
• Discussing on Investigator initiated studies and the funding support from the pharmaceutical industries
• Abstracting the necessary information on researchers planning to perform a clinical trial in India.
Moderator
S.R.SALUNKHE, Former Assistant commissioner, FDA Maharashtra
Panellists
RUBINA BOSE, Deputy Drugs Controller(India), CDSCO (WZ)
OMPRAKASH S. SADHWANI, Former Joint Commissioner and controlling Authority, Food and Drug Administration (Maharashtra state)
YASMIN SHENOY, Director-Regulatory Affairs, Sanofi-aventis
AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis
PRANJAL BORDOLOI, AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research
16:50 - Chairperson’s closing remarks and end of conference
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