Lex Witness will present the 2nd Annual Pharma Legal & Compliance Summit 2013, which will be held in Mumbai on September 27, 2013.
Pharma companies in India are facing a challenge of an increasing complex, demanding and fast-changing logistics and regulatory environment. Traditional approaches are being challenged by shorter market cycles, outsourced production, and increasing government regulations. Multinational pharma companies are increasing efforts to strengthen their presence in India through research investment, licensing deals, co-marketing arrangements, acquisitions, or other partnerships. 25 per cent of proposals received by FIPB are for pharma. On the other hand, approval timelines and over restrictive regulations are giving thoughts for India-centric pharma organisation for establishing base in countries offering transparent regulations.
The recent changes in regulation and agencies involved in regulatory oversight means a catch up game to analyse business impact on short and long-term strategy for legal, regulatory, compliance and commercial professionals operating in the pharma space. With increasing management expectations on business strategy formulation from senior professionals, especially in a complex regulatory environment, the 2nd edition of Pharma Legal and Compliance Summit is the best investment of time to analyse, interpret and strategise the current and future response to legal, regulatory and compliance challenges.
Discussions will be held on: How to use compliance and ethical business practices as competitive business advantage?; Key elements of a compliance programme; Analysis of Legal and Regulatory Updates; Section 3d of Indian Patent Act; Patent Litigations: Recent Case Updates and Analysis; Grey areas of Competition Law; Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and Pharma M&A Contract and FDI.
The confirmed speakers for the summit are AS Kumar, General Counsel, Dr Reddy’s Laboratories; Abhayan Jawaharlal, Chief Legal Officer, Cipla; Ajay Thomas, Registrar, LCIA India; Ashok Bhuta, DGM (Legal & Secretarial) as Compliance Officer, Sun Pharma Industries; Atul Bonde, Regulatory Affairs, Cipla; Atul Moghe, Deputy General Manager – Regulatory Affairs, Mylan Laboratories; Darshini Bhatt, AGM IPR, Troikaa Pharmaceuticals; Debolina Partap, Associate Vice President & Head Legal, Wockhardt Group, India; Deepak S Pandya, VP (Legal) and Company Secretary, Dishman Pharmaceuticals & Chemicals; Durgesh Paliwal, Head – Legal, Abbott Laboratories; Ghanashyam Hegde, Senior Legal Counsel, Abbott India; Marshall Mendonza, Independent Legal Professional; Nilesh Shah, AGM- Legal, Alembic Pharmaceuticals; Rajeev Mukundan, General Counsel and Chief Compliance Officer, Mylan Laboratories; SP Date, Company Secretary and Compliance Officer, Elder Pharmaceuticals; Sheela Vadavalli, Vice President Legal and Compliance Officer, Mylan Pharmaceuticals; Susheela, Head IP, Biocon; Vivek Mittal, Head – Legal, Lupin; Yasmin Cama, Senior Director – Legal Affairs, Sanofi-Aventis Group, India.
EP News Bureau – Mumbai