New York, NY, March 03, 2016 --(PR.com
)-- The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Linda Chatwin (on behalf of MasterControl), Head of the North American Advisory Services group, Underwriters Laboratories (UL) will speak at the Knowledge Group’s webcast entitled: “Strategic Patent Portfolio and Lifecycle Development for Pharma & Biotech Industries in 2016.” This event is scheduled for March 31, 2016 from 12:00pm – 2:00pm (ET).
For further details, please visit:
About Linda Chatwin
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.
MasterControl is a committed team of quality, regulatory and software experts who work to empower regulated companies to get their products to market faster. MasterControl’s quality management software solutions reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage for customers. Drawing upon unparalleled industry experience, MasterControl offers a suite of seamlessly integrated and scalable software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management and much more. MasterControl’s complete quality management solution is designed for easy implementation, validation and use, continually improving on the promise of Compliance Accelerated. For more information about MasterControl, visit www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); +81 (03) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).
Generic competition relentlessly poses a threat for pharma and biotech lifecycles. With its growing complexity, companies with poor product lifecycle management strategies are more likely to be exposed to legal challenges and revenue risks. Thus, it is crucial for companies to establish and maintain a robust life cycle management strategy to minimize possible loss and liabilities. In a two-hour Live Webcast, a panel of key thought leaders, professionals and regulators assembled by The Knowledge Group will help the audience understand the most significant issues with respect to portfolio strategies in pharmaceutical and biotechnology patent lifecycle management and development. The panel will also share their expertise and insights on how to best maintain an effective and efficient patent portfolio in biotech and pharma lifecycle.
Key topics include:
• Pharmaceutical and Biotechnology Patent Life Cycles – An Overview
• Patent Term Adjustments for Biotech and Pharma
• Role of PTA in Biotech and Pharma Patent Life Cycle
• Patent Term Extensions, including SPCs in Europe
• Patentability and Implications for Life Sciences Innovation
• Portfolio Strategies
• Common Risks and Pitfalls
• Up-to-the-minute Regulatory Updates
About The Knowledge Group /The Knowledge Congress Live Webcast Series
The Knowledge Group was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register for an event, please visit: http://theknowledgegroup.org/.