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Masterclasses

» Masterclass A - IP Protection in Outsourcing Biologics Manufacturing
» Masterclass B - Preparing EU Risk Management Plan (EU-RMP) for Biosimilars Marketing in EU
 

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Masterclass A
IP Protection in Outsourcing Biologics Manufacturing
The wave of foreign outsourcing is continuing to fuel the expansion of India’s biopharmaceutical industry. However, India is not yet reaching their full potential, as fears over inadequate intellectual property (IP) laws are holding many international companies back. This masterclass will address the current state of intellectual property (IP) law development in India, highlight case studies and strategies to adequately protect your IP while outsourcing R&D and manufacturing to India, and evaluate the implications of IP protections when planning for outsourcing strategies in India.
 
This masterclass will address the following issues:
• Venturing into India: Exercising IP Due Diligence.
• Biopharmaceuticals IP Enforcement & Litigation in India.
• Case Studies of Outsourcing to India.
• Outsourcing to India: Key IP protection provisions in contracts.
• The Interface between Biopharmaceutical IP, Competition and Regulatory Laws, and Government policy in India.
 
Benefits of attending:
• Understand the current state of IP protection in India.
• Gain insights into the challenges associated with identifying suitable advisors and conducting IP risk analysis/freedom to operate.
• Evaluate the importance of IP due diligence to secure protection.
• Assist participants identify where weaknesses exist and the risk posed by such weaknesses
• Learn from real life case studies presented by end-users in assessing various key factors crucial to outsourcing decisions.

Who should attend?
• CEO, COO, CTO, CSO, CLO
• Head of Licensing
• Head of Business Development
• Head of New Technology Development
• Head of Strategic Alliances
• Head of Search and Development
• Head of Marketing
• Patent Agent/ Partner/ Attorney/ Legal Counsel
• Commercialisation Officer
• Venture Capitalist
• Analyst

Masterclass Leader:

Anindya Sircar

Anindya Sircar, Global Head of IP, Biocon Group of Companies, India

Dr. Anindya Sircar heads the IP department for the Biocon Group – a premiere biotechnology company in Bangalore, India. He has over 10 years of experience in handling different aspects of IP and was intstumental in setting up the IP Department for the Biocon Group. Besides, he is a Visiting Faculty on IP at NALSAR University of Law, Hyderabad; National Law School of India University, Bangalore; PEXA, Mumbai and IBAB, Bangalore. He takes active participation in patent awareness programs and other programs involving search techniques for patent and commercial information. He has been a resource person for numerous workshops and conferences on IP, also a member of Special Interest Group on IP of ABLE; member of the CII National Committee on Technology and IPR and National Committee of Intellectual Property Owners. He is also an Emeritus Member of the Advisory Board of Dialog-Thompson, UK. He is also a member of the Expert Committee on “Intellectual Property Rights” of the Karnataka Biodiversity Board. Dr. Sircar holds a PhD in Microbiology, a PhD in Law and is a registered Patent Agent. 

Co-conductors:

V.C. Vivekanandan, MHRD IP Chair Professor of Law, National Academy of Legal Studies and Research University of Hyderabad, India

Abhayan Jawaharlal, Head - Group Legal, Biocon Limited, India


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Masterclass B
Preparing EU Risk Management Plan (EU-RMP) for Biosimilars Marekting in EU 
Article 8(3) (ia) of Directive 2001/83/EC, as amended (incl. Biosimilars) as well as EMEA guidance (CHMP/96268/2005), requires that a marketing authorisation application (MAA) for new products as well as Biosimilars shall include, where appropriate, the detailed description of the risk management system that the applicant will introduce.

A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions.

The aim of a risk management system is to ensure that the benefits of a particular medicine (or a series of medicines) exceed the risks by the greatest achievable margin for the individual patient and for the target population as a whole.
 
This masterclass will address the following issues:
• Safety specifications
• Pharmacovigilance plan
• Risk minimisation plan
• Evaluation of acceptable risk vs. benefit
• Minimisation and effectiveness of measures
 
Benefits of attending:
• Understand the EU requirements in terms of safety assessments for Biosimilar product development
• Gain insights into the challenges associated with Detection & Identification of safety signals
• Evaluate the importance of Risk Minimisation Plan (RMP) for Biosimilar Dossiers
• Risk minimization activities/tools required
 
Who should attend?
• Regulatory Professionals
• Business Development & Marketing
• New Technology Development
• Professionals in Strategic Alliances, Research and Development
• Venture Capitalist

Masterclass Leader:

Parminder Kaur, Regulatory Leader, OctoPlus, The Netherlands

Ms. Parminder Kaur is a Regulatory Affairs professional with global expertise and has been working in the field of regulatory affairs for the last 10 years. Ms. Kaur has hands-on experiences in pharmaceutical and biotechnology industries and interaction with major Regulatory Authorities worldwide. She has provided strategic input for regulatory matters regarding new product development aimed for global launch, development of Biosimilars for EU market as well as registration of old vaccines in the EU.
Apart from dealing with Clinical Trial and Marketing Authorisations Applications, Variations Applications, Drug Master Files, Orphan Drug Designations, Paediatric Investigational Plans (PIP) and Scientific Advice meetings, Ms. Kaur has also been highly involved in the Pharmacovigilance set-up at various companies and has been involved to a great extent with writing and managing pharmacovigilance plans, risk minimization plans and SAE reporting procedures.

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