Pharma Regulatory 2018

Pharma Regulatory 2018

15th March 2018, Kohinoor Continental Hotel, Mumbai, India

"Understanding recent regulatory developments to explore innovative strategies"

Virtue Insight brings you it’s first Pharma Regulatory 2018, focusing on the clarification and interpretation to the most critical regulatory guidelines faced by the Indian Pharma companies.This unique event will bring key stakeholders gather with the aim of promoting and undertaking to continue work towards a more efficient pharma regulatory system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals. The summit features government and regulatory authorities and expert insights to help you tackle and overcome these regulatory challenges, and to improve the drug and device approval processes for pharmaceutical, biopharmaceutical and medical device companies.

KEY SPEAKERS:

• RAJENDRA SANGHAVI, Sr. Consulting Clinician & Chairman - Medical, Committee, Indian Drug Manufacturers’ Association (IDMA)
• DEBOLINA PARTAP, Vice President Legal & GC, Wockhardt
• RAHUL GUPTA, Vice President, Regulatory Affairs, USV
• PRASHANT DESAI, Director – Regulatory Affairs & Business Quality, Johnson & Johnson
• YASMIN SHENOY, Director-Regulatory Affairs, Sanofi-Aventis
• SRIRUPA DAS, Associate Director - Medical Affairs, Abbott
• NAVEEN KUMAR NAGARAJA, Assistant Director Regulatory Affairs, Takeda
• SHANTANU MUKHERJEE, Legal Head, Asia Pacific and Japan, Lupin
• KEDAR SUVARNAPATHAKI, Head - Regulatory Affairs & IP, Boehringer Ingelheim
• SANJAY KUMAR, Head of Legal Ethics & Compliance, GSK Consumer Healthcare R&D India
• AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis
• NARESH TONDARE, Head – India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
• SONIKA SHAH, Regulatory Affairs Head, Amgen
• QAYUM MUKADDAM, Independent Consultant, (Former Head- Medical & Regulatory Affairs -Galderma India)
• RITU JOHARI, Head-Scientific Affairs, Quality & Regulatory, Abbott Diabetes Care
• ALAP GANDHI, Head, Medical Affairs, GSK
• RANJIT BARSHIKAR, QbD / CGMP Consulting, Editorial Member of Journal of Generic Medicine-England
• PRATIK SHAH, Head- Clinical, Medical & Regulatory Affairs,, PV and QA Astellas Pharma

KEY THEMES DISCUSSED:-

Registration, Compliance and Approval, Scientific and regulatory challenges worldwide, Product registration and current regulatory intels, Regional government updates on initiatives, cutting backlogs, current guidelines, Regulatory landscape, Evaluating the regulatory anticipations, opportunities and challenges for biosimilar orphan drugs, Drug approval blockades , Investigating the regulatory surroundings for biosimilars in India, The challenges of the Indian Regulation , Pharmacovigilance Regulations , Deciding better schemes for registering a variation and gaining approval in India, Comprehensive views on OTC product registration, License, Compliance, Safety and Risk Control, Cutting down the backlog of Clinical Trial and Marketing Applications , Regulation analyses , Supply chain, Labelling and Distribution,Standards and cooperative strategies needed

WHO SHOULD ATTEND:-

Specifically designed for pharma, biotech, CRO’s, Government and Regulators, Hospitals/Trial Sites, Technology & Solution Providers and med device professionals responsible for

Regulatory AffairsRegulatory Writing/Medical Writing/Publishing/Information/Submissions, Document and eRecords Management, Business Operations/Processing, Labelling, Clinical Trials Management/Data, Clinical Data, Outsourcing/Clinical Outsourcing/Vendor Management, Product Development, Quality Assurance/Quality Control

CONFERENCE REGISTRATION PROCESS:

• Early Bird Discounted Price (Until 28th January 2018 ) – 1 Delegate Pass - (INR 6,000 + GST (18%) per delegate)
• Standard Price (From 29th January 2018) –  1 or 2 Delegates - (INR 7,000 + GST (18%) per delegate)
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + GST (18%) per delegate)
• Group Discounts – 5 and above Delegates - (INR 6,000 + GST (18%) per delegate)
• Spot Registration on the day of the Conference – 1 Day Conference - (INR 8,000 + GST (18%) per delegate)
• Conference Sponsor, Exhibition Stall and a paid Speaker Slot are also available.

Join this one day strategical summit which provides insights on the US, Europe and ROW region which presents the major revenue of the top Indian pharmaceutical companies and explore the regulatory developments and  innovative strategies.