PRINCETON, N.J., March 9, 2016 /PRNewswire/ -- In two different sessions, Subject Matter Experts from Navitas will address new challenges facing the life science industry created by the acceleration of the globalization of the life science industry, new regulatory requirements and unprecedented merger and acquisition activity. They will talk about solutions to these challenges, demonstrating real world approaches derived from successful pharma company projects, and insights from Navitas' industry leading networks pvnet® and labelnet®. Our networks are independent communities where life science leaders facing similar challenges exchange insights, compare performance, and debate strategies to tackle the latest hot issues. With over 100 members from the world's leading life science companies, each network has a focused and evolving agenda to meet the latest challenges.
Tuesday, June 28th 10:30am: Hershell Thompson will chair "The Global Conundrum: Herding Cats – Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi – Country Pharmacovigilance Activities". Along with Lesia Tontisakis of Allergan and others, this session explores the Pharmacovigilance (PV) Affiliate Network from both corporate and local perspectives, reviews case studies of issues faced by companies of all sizes, from start-up to multi-national. In addition, an approach to clarifying the current affiliate situation using an affiliate's survey tool, as well as available in-house data sources will be presented. Also, how risk-assessment approaches can be applied to generate a clear view of systemic risk (exposure across all or many affiliates) and unique risks (exposure specific to one particular or a few local affiliates). Finally, methods to streamline PV affiliate processes and the benefits this approach provides to the enterprise with be highlighted.
Tuesday, June 28th 4:30pm: Denis Fung and Brenda Crowe of Eli Lilly will present "Improving Adverse Drug Reaction Information in Product Labels". Adverse drug reactions (ADRs) are an important part of a product label. This session will recommend ways to make ADR information in product labels more understandable and better reflective of the risk of a drug relative to a comparator. The session will also explore the importance of end-to-end labeling and tracking to ensure pharmacovigilance compliance.
The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting. We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advice, solutions, and services in Clinical, Regulatory, Safety, and Content Management. We are proud that our legacy businesses have served the sector for some 15 years and have allowed us to work with 100 of the top Life Science companies. Our team has now grown to over 400 staff.
We pride ourselves in our role as Expert Navigators. Interpreting market and regulatory change; driving collaboration across companies; seeking the simple solution to the complex problem; investing to enable the changes. We are motivated by the success of our clients and thrive on working together with clients, partners, and each other, across geographies, time zones, and cultures. For more information, visit www.navitas.net
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