Conference Overview:
Indian pharmaceutical industry is third largest in the world and is one of the most developed industries. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. Through the introduction of a system of product patents since 2005, Indian industry has today become very a worldwide exporter of high quality generic drugs. India exports pharmaceuticals to many countries across the world, including the U.S., Germany, France, Russia and UK.
This conference will deliberate on a review and assessment of regulatory issues in the Indian pharmaceutical industry. Understanding the regulatory scenario in this sector is extremely crucial not only due to the rapid and ongoing changes at the global level, largely with reference to good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP) but also due to the onus on the regulatory bodies to ensure a healthy supply of quality drugs at affordable prices to the Indian masses as well as for overseas exports.
We at Blackarrow Conferences understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements; hence we are trying to simplify things for you by assembling the stalwarts of the Pharma industry at this conference to provide their key insights on important Indian guidelines and regulations.
Click here to see Schedule Y of the Drugs & Cosmetics Rules
Indian pharmaceutical industry is third largest in the world and is one of the most developed industries. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. Through the introduction of a system of product patents since 2005, Indian industry has today become very a worldwide exporter of high quality generic drugs. India exports pharmaceuticals to many countries across the world, including the U.S., Germany, France, Russia and UK.
This conference will deliberate on a review and assessment of regulatory issues in the Indian pharmaceutical industry. Understanding the regulatory scenario in this sector is extremely crucial not only due to the rapid and ongoing changes at the global level, largely with reference to good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP) but also due to the onus on the regulatory bodies to ensure a healthy supply of quality drugs at affordable prices to the Indian masses as well as for overseas exports.
We at Blackarrow Conferences understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements; hence we are trying to simplify things for you by assembling the stalwarts of the Pharma industry at this conference to provide their key insights on important Indian guidelines and regulations.
Click here to see Schedule Y of the Drugs & Cosmetics Rules
Supporting Organisation: All India Association of Industries
AIAI Established in 1956 in Mumbai, the commercial capital of the country by Shri Babubhai M. Chinai, M.P. The AIAI has over 1400 members and through its affiliates it represents over 30,000 industries. Nearly 70 percent of its members are from the SME sector. With sweeping changes brought about by rapid globalization, mergers and takeovers having become the order of the day, with new challenges for industry to a large extent AIAI meets the requirement of SMEs in this process.
Today, the Association is led by Vijay Kalantri as the President with Rupa Naik as the Executive Director.
Today, the Association is led by Vijay Kalantri as the President with Rupa Naik as the Executive Director.
Supporting Organisation: James Lind Institute
James Lind Institute (JLI) is an educational division of Clinexa Life Sciences. Clinexa is a Contract Research Organization (CRO) making its mark in niche areas of clinical research. The organization is certified by the International Standards Certifications Pty Ltd. as per ISO 9001:2008 standards for providing Training & Education Programs in Health Sciences.
James Lind Institute's online programs are globally recognised and fully accredited by the International Accreditation Organization (IAO), Houston, U.S.A.
James Lind Institute's online programs are globally recognised and fully accredited by the International Accreditation Organization (IAO), Houston, U.S.A.
Media Partner: pharmaphorum
pharmaphorum is the primary facilitator of thought leadership and innovation within pharma. We support the next generation of pharmaceutical industry leaders through producing, curating and publishing media that will help pharma embrace the challenges of being a healthcare solutions provider in the 21st century. Visit www.pharmaphorum.com today to discover what is shaping the future of your industry, including daily new opinions pieces, interviews, news, showcase service providers, events and job opportunities or get in touch to see how we can help you better communicate your ideas and vision within pharma.
Conference Agenda: 31st January 2013
This Blackarrow Conference shall discuss the recently introduced guidelines for GCP. You shall hear from the industry experts about their views on the implications of these guidelines. This 1 day conference shall try to cover some of the most pressing issues for the Pharma industry.
09:00am - Registrations & Networking Breakfast
09:30am - 9:45am Keynote Presentation
Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS)
09:45am - 10:00am Keynote Presentation
10:00am - 11:30am
Q&A session
11:30am - 11:50am Tea/Coffee Break
11:50am - 01:20pm
Dr. Pratik Shah - Head Clinical Research & Development, Astellas Pharma India
Q&A session
01:20pm - 02:00pm Networking Lunch
02:00pm - 03:00pm
Panelist: Dr Madhuri Jadhav - Global Head-Quality Assurance, Compliance & Training, Karmic Lifesciences
03:00pm - 03:30pm
03:30pm - 03:50pm Tea/Coffee Break
03:50pm - 05:20pm
Dr Krathish Bopanna - President & Chief Executive Officer, Semler Research Center
Q&A session
Bonus Session: CLINICAL TRIAL SANCTION UNDER INDIAN LAW
Speaker: Rahul Dutta - Advocate, Intellectual Property Lab
This Blackarrow Conference shall discuss the recently introduced guidelines for GCP. You shall hear from the industry experts about their views on the implications of these guidelines. This 1 day conference shall try to cover some of the most pressing issues for the Pharma industry.
09:00am - Registrations & Networking Breakfast
09:30am - 9:45am Keynote Presentation
- GLOBAL & INDIAN PHARMACOVIGILANCE REGULATIONS
Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS)
09:45am - 10:00am Keynote Presentation
- Speaker: Solomon Yiman, Assistant Country Director, US FDA India Office
10:00am - 11:30am
- GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR DRUGS
Q&A session
11:30am - 11:50am Tea/Coffee Break
11:50am - 01:20pm
- GUIDELINES ON ENSURING RIGHTS/ SAFETY OF CLINICAL TRIALS SUBJECTS IN INDIA
Dr. Pratik Shah - Head Clinical Research & Development, Astellas Pharma India
Q&A session
01:20pm - 02:00pm Networking Lunch
02:00pm - 03:00pm
- Panel Discussion: GUIDELINES ON REPORTING SERIOUS ADVERSE EVENTS OCCURING IN CLINICAL TRIALS
Panelist: Dr Madhuri Jadhav - Global Head-Quality Assurance, Compliance & Training, Karmic Lifesciences
03:00pm - 03:30pm
- PHARMA COVIGILANCE - A SERIOUS BUSINESS
03:30pm - 03:50pm Tea/Coffee Break
03:50pm - 05:20pm
- GUIDELINES FOR DETERMINING QUANTUM OF FINANCIAL COMPENSATION TO BE PAID IN CASE OF CLINICAL TRIAL RELATED INJURY OR DEATH
Dr Krathish Bopanna - President & Chief Executive Officer, Semler Research Center
Q&A session
Bonus Session: CLINICAL TRIAL SANCTION UNDER INDIAN LAW
Speaker: Rahul Dutta - Advocate, Intellectual Property Lab
Who Should Attend:
This one day conference is targeted to Heads of
This one day conference is targeted to Heads of
- Regulatory Affairs
- Legal
- Compliance / Vigilance
- Clinical Trials / Research
- Clinical Investigations
- Distribution & Storage
Keynote Presentations by
Y K Gupta Dr : National Scientific Coordinator Pharmacovigilance Program of India (CDSCO)
Dr. Y.K. Gupta M.B.B.S, M.D, FIPS, FNASc, FAMS, FIAN, FTOX is presently the Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi. He earlier served as Director of the Indian Institute of Toxicology Research Toxicology Research (IITR), Lucknow between 2003-2005. He has more than 170 publications in International and National journals and has been awarded several honors including the Indian National Science Academy (INSA) young scientist medal, G. Achari Oration Award of Indian Pharmacological Society, (IPS), Major General S. L. Bhatia Oration Award, Association of Physiologist and Pharmacologist of India (APPI), AEB honours award by the Academy of Environmental Biology, etc.
|
Solomon Yiman: Assistant Country Director
|
Confirmed Speakers on the Conference Include
Anish Desai Dr : Director Medical Affairs & Clinical Ops - Johnson & Johnson Medical
Anish currently is Director - Medical Affairs and Clinical Operations at Johnson & Johnson Medical. Prior to this he was with Bayer Healthcare, Bayer Schering Pharma, Mumbai where he was working as Head of R&D/Medical Director handling Medical Affairs, Clinical Operations, Regulatory Affairs and Pharmacovigilance & was responsible for new product registration and Clinical Development for local and global requirements. Anish was actively involved in conducting CMEs and Key opinion leader development. He was also responsible for drug safety and handled an additional portfolio of Market access and Governmental affairs. He has the experience of handling external agencies like DCGI, DGFT, ICMR and CDL/CDTL. Anish was awarded the Golden Star Award at a global platform for partnering across boundaries. He has been trained by ICMR a premier governmental research body in Clinical Pharmacology. Anish has an overall experience of over 20 yrs in Industry, Academia and Research.
Arun Bhatt Dr : President - Clininvent Research
Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry. He has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include 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. Dr Bhatt is recipient of Drug Information Association outstanding Service award 2012 for his immense contributions in his field of specialization.
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 – Your Questions Answered”.
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 – Your Questions Answered”.
Krathish Bopanna Dr : President & Chief Executive Officer - Semler Research Center
Dr. Bopanna has over 17 years of experience in Pharma R & D mainly in the areas of medical, clinical and regulatory and has served leading positions in AstraZeneca, Manipal Acunova and Tata Consulting Services. Dr. Bopanna is a thought leader and currently holds the position of President, Indian Society of Clinical Research and serves in several task forces of the government and industry bodies. He serves as the member of advisory council of India for DIA. Dr. Bopanna has chaired and co chaired organisation of many national and International conferences. He is a trained pharmacologist with a doctorate in psychopharmacology from the national Institute of Mental Health and Neurosciences (NIMHANS), Bangalore and a Doctor of Science in biochemical pharmacology from International University of Washington DC.
Madhuri Jadhav Dr : Global Head-Quality Assurance, Compliance & Training- Karmic Lifesciences
Dr. Madhuri Jadhav is a dedicated professional with a collective and extensive experience of 20 years in various areas of clinical research and in academics. She has managed various roles and responsibilities in different capabilities, viz. Project Management (phase II-IV studies), Pharmacovigilance, Clinical Trial Supplies Management, Training and Development, Line Management, establishing/operationalizing Quality Management Systems, Quality Assurance and Virtual Drug Development Outsourcing. Dr. Jadhav is a Ph.D. (Tech. in Pharmacy) from Kundnani College, Mumbai and Diploma in Clinical Research and Quality Management.
Moin Don: Executive Director - PVCON Pharmacovigilance Consulting & Auditing Services
Moin has over 33 years experience in the pharmaceutical industry. Pharmacist by education, Moin is one of the most well known ‘Pharmacovigilance Professionals’ in India. He has rich hands on experience of practically every facet of Industrial Pharmacovigilance, while serving reputed international pharmacos like Sanofi Aventis & his last assignment being, with Johnson & Johnson as Regional PV QA Director for Asia Pacific. Moin has undergone extensive training in U.S, Germany, France & Singapore and is a certified ‘Lead Auditor’. He is one of the co-author in developing the protocol for ‘India’s National Pharmacovigilance Programs. In addition Moin is also a member of the Central Advisory Committee of DIA India. He is a visiting faculty & international speaker & author whose articles have been published in international journals of repute.
Pratik Shah Dr: Head Clinical Research & Development - Astellas Pharma India
Dr Shah is currently Head Clinical Research & Development with Astellas Pharma India Pvt Ltd, Japanese MNC with products in Transplantation, Urology, Dermatology, etc. In current responsibility, he is in charge of all the clinical trials and medical affairs activities of the company. He has an MD in pharmacology from Nair Hosptial, Mumbai & also done Post Graduate Diploma in Pharmaceutical Management and Post Graduate Diploma in Clinical Research and Trial Management. Earlier, he was looking after medical affairs in Johnson & Johnson in charge of Nephrology business unit as Medical Advisor where he was responsible for 4 clinical projects in collaboration with Harvard Medical School, Boston in field of Nephrology.
Rahul Dutta - Advocate, Intellectual Property Lab
Rahul is an LL.M IP, Gold Medalist from the National Law University, Jodhpur. He has also done his DL-101 and DL -204E (IP and Biotechnology) Course of WIPO Academy & the WIPO PCT Course. He is currently into independent IP practice. I have nine years work experience in IP. His international publications include: ‘Anti-Competitive Trade Practice and Data Protection in Indian Perspective’, Vol. 5 No. 1 2010 MARCH, Korea Institute of Intellectual Property; ‘Trademark Assignment in India in the Light of a latest Judgment’, December 2009, LES-Nouvelles & ‘Due Diligence Threads in Indian IP Laws’, Volume XLVI No.1, March, 2011, LES-Nouvelles
Shravanti Bhowmik Dr : General Manager Clinical Research - Sun Pharma Advanced Research Company
Dr Shravanti is curently General Manager Clinical Research at Sun Pharma Advanced Research Company. She is incharge of clinical Operations and Development for SPARC's NCE and NDDS projects in India and ROW. She is also overlooking Outsourcing and budgets, Pharmacovigilance, Medical writing & Overall project management. She was earlier Lecturer of Pharmacology at Medical College Pune.
Yasmin Shenoy Dr : Director Regulatory Affairs - Sanofi-Aventis India
Dr Shenoy employed with the Indian affiliate of Sanofi since the last 16 years. Responsible for obtaining regulatory approvals for all Sanofi products in India, Nepal and Sri Lanka. Academic Qualifications : Masters in Pharmacy (Pharmaceutics) & PG Diploma in Patent Management. Professional Associations : Member of OPPI (Organization of Pharmaceutical Producers of India) and ISCR (Indian Society for Clinical Research)
Additional Information : Recipient of the ‘Mahindra & Mahindra Search for Talent’ Scholarships for securing first position during B Pharm & M Pharm (1992, 1993, 1994 and 1995). Awarded J R D Tata Scholarship for Post-graduate Studies in 1994 and 1995
Additional Information : Recipient of the ‘Mahindra & Mahindra Search for Talent’ Scholarships for securing first position during B Pharm & M Pharm (1992, 1993, 1994 and 1995). Awarded J R D Tata Scholarship for Post-graduate Studies in 1994 and 1995
Invited Speaker Organisations include:
- Directorate General Of Health Services
- Central Drug Standards Control Organization, West Zone
- Drugs Controller General of India
- Indira Gandhi Medical College
- IPGMER -SSKM Hospitals
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
- TN Medical college & BYL Nair Charitable Hospital
|
Conference Venue: J W Marriott Hotel, Juhu - Mumbai
Experience one of the premier luxury hotels in Bombay - JW Marriott Hotel Mumbai. Located on the Juhu beach, overlooking the scenic waters of the Arabian Sea, this Mumbai luxury hotel's guest rooms and restaurants are favorite hotspots of Bollywood celebrities and business travelers. Featuring 14,000 square feet of stunning event space, this luxury hotel is Mumbai's most lavish venues for conferences. |
|
We request you kindly spare a few moments of your valued time to go through our past event on GCP Regulatory Inspection Course we helped organise for a well known association.
Click here to view our past Pharma event
Click here to view all our past events
Click here to know more about the organisers
Click here to view our past conference galleries
Click here to view our past Pharma event
Click here to view all our past events
Click here to know more about the organisers
Click here to view our past conference galleries
