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
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 - 10:00am Keynote Presentation Speaker: Dr. Y. K. Gupta - National Scientific coordinator, Pharmacovigilance Program of India (CDSCO) and
Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS)
10:00am - 11:30am Speaker: Dr Yasmin Shenoy - Director Regulatory Affairs, Sanofi-Aventis India
Dr. Usha Gupta - Vice President, Delhi Society for Promotion of Rational Use of Drugs
Q&A session
11:30am - 11:50am Tea/Coffee Break
11:50am - 01:20pm Speaker: Dr Arun Bhatt - President, Clininvent Research
Dr. Pratik Shah - Head Clinical Research & Development, Astellas Pharma India
Q&A session
01:20pm - 02:00pm Networking Lunch
02:00pm - 03:00pm Moderator : Dr Anish Desai - Director Medical Affairs & Clinical Ops, Johnson & Johnson Medical
Dr Madhuri Jadhav - Sr Ass Director Clinical Operations, Karmic Lifesciences
03:00pm - 03:30pm Speaker: Mr Moin Don - Executive Director, PVCON Pharmacovigilance Consulting & Auditing Services
03:30pm - 03:50pm Tea/Coffee Break
03:50pm - 05:20pm Speaker: Dr Shravanti Bhowmik - GM Clinical Research, Sun Pharma Advanced Research Company
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
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
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 - 10:00am Keynote Presentation Speaker: Dr. Y. K. Gupta - National Scientific coordinator, Pharmacovigilance Program of India (CDSCO) and
Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS)
10:00am - 11:30am Speaker: Dr Yasmin Shenoy - Director Regulatory Affairs, Sanofi-Aventis India
Dr. Usha Gupta - Vice President, Delhi Society for Promotion of Rational Use of Drugs
Q&A session
11:30am - 11:50am Tea/Coffee Break
11:50am - 01:20pm Speaker: Dr Arun Bhatt - President, Clininvent Research
Dr. Pratik Shah - Head Clinical Research & Development, Astellas Pharma India
Q&A session
01:20pm - 02:00pm Networking Lunch
02:00pm - 03:00pm Moderator : Dr Anish Desai - Director Medical Affairs & Clinical Ops, Johnson & Johnson Medical
Dr Madhuri Jadhav - Sr Ass Director Clinical Operations, Karmic Lifesciences
03:00pm - 03:30pm Speaker: Mr Moin Don - Executive Director, PVCON Pharmacovigilance Consulting & Auditing Services
03:30pm - 03:50pm Tea/Coffee Break
03:50pm - 05:20pm Speaker: Dr Shravanti Bhowmik - GM Clinical Research, Sun Pharma Advanced Research Company
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
Invited Speaker Organisations include:
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.
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