The pharmaceutical and bio pharma sector in India is witnessing a change in their business dynamics. The recent proposal by government to codify ethics for pharma companies with uniform code of pharma marketing practices and recent changes in MCI guidelines on gifting to doctors and medical professionals and a strong DGCI follow up in certain cases means that it is no longer business as usual.
Tapping into the urgent need for pharma companies to proactively manage their internal process on governance, ethics and compliance to protect against potential financial penalties, possible product withdrawals and damaged reputations, Lex Witness, India’s first magazine on legal and corporate affairs will organise a first of its kind Pharma Legal & Compliance Summit (PLCS 2012) on October 5, 2012 at Hotel Holiday Inn in Mumbai. India’s first comprehensive discussion will deal with important issues affecting the industry on governance, ethics, compliance, contracts management, licensing agreements and developing a proactive legal strategy for patent litigations.
Besides the increased competitive pressure and closer scrutiny of regulators and other stakeholders, there is significant investment in R&D by pharma companies and high level of collaboration and cooperation between Indian and multinational pharma companies in contract research and manufacturing. Managing and negotiating contracts, licensing agreements and having an effective patent strategy thus becomes more important than ever to avoid disputes which have an adverse financial and reputational impact on both parties.
A full day convention, PLCS aims to offer an opportunity to all stakeholders in the industry, including law firms, pharma and bio pharma firms, bio tech firms, copyright societies, regulatory and patent filing consultants to share their views on the grave concerns affecting their business.
The expert speakers’ panel will feature more than twenty proficient speakers consisting legal practice Partner, VPs, functional heads, legal head, general counsel, general manager legal and compliance and company secretaries of industry’s few best known companies. To name a few, pharma giants like Biocon, Wockhardt Group, Cipla, Cadila Healthcare, Abbott India, Novartis India, GlaxoSmithKline Pharmaceuticals are going to take part in the event.
Some of the key areas of debate will focus on Fraud and Corruption Management, Legal and regulatory compliance of ethics for pharma and bio-pharma companies in India, legal risk management strategies for new product launches, current regulatory developments and implications of changes to regulatory framework, trends in patent opposition and litigation, recent developments in pre-grant and post-grant opposition, settlement strategies, key elements of a compliance programme, recent changes in clinical trials documentation requirements in India, current legal issues in domestic and cross border site contracts and contracts, claims and counter claims and licensing agreements.
The PLCS 2012 initiative is sponsored by Legasis as Knowledge partner, TMT Law Practices and PSA as Silver partners, Laser GRC Solutions as Technology partner and Society of Indian Law Firms (SILF) as Supporting partner. The media partners to the summit include Express Pharma, India Law Journal, Lawyers Club India, Think Legal and National Bar Association of India.
EP News Bureau
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