The latest regulatory information management (RIM) Webinar and breakfast briefing will take place on 7 October and 10 October, respectively,
Paris – 2nd October, 2014 – Life sciences outsourcing and consulting services specialist ProductLife Group (PLG) has announced Merck Serono as a key presenter in the second of its PLG Evolve autumn programme events.
The latest regulatory information management (RIM) Webinar and breakfast briefing will take place on 7 October and 10 October, respectively, and will feature a key presentation by Heinz Venghaus of global regulatory and quality assurance at Merck Serono. Heinz will recount Merck Serono’s regulatory information management journey by detailing the challenges the company faced, the steps taken to achieve a single source of the truth, and goals for the future. ProductLife Group’s senior consultant Catherine Gambert will present insights on RIM and its wider benefits for life sciences companies.
Companies are under pressure on the compliance and business fronts to improve the management of their regulatory information. They must be able to assure the authorities that they know what they have on the market, that certifications are being kept up-to-date, and that the latest label and safety information is being maintained for all products in all markets.
In response, Merck Serono is working to make sure it has a single source of the truth with regard to both content-related data and metadata for any given marketing authorisation. To that end, the company has undergone a dramatic overhaul of the way it communicates and shares information between headquarters and regulatory affairs affiliates.
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About the speakers
Heinz Venghaus is senior project manager of regulatory informatics and submission management in Merck Serono’s global regulatory and quality assurance department, where he leads the implementation and global rollout of Merck Serono’s RIM systems. Heinz has 12 years of experience in leading international projects in the areas of regulatory affairs and information technologies in the life sciences and pharmaceutical industries.
Catherine Gambert is a senior consultant in regulatory affairs and regulatory information systems at ProductLife Group, where she applies expertise in comprehensive RIM programmes, including migrations and mergers of systems, master data management, and governance and data quality for regulatory information systems. Catherine has 28 years of experience in R&D as well as extensive experience in global regulation operations. Before joining PLG, she was with Merck Serono.
Future events in the PLG Evolve programme—including additional Webinars, briefings, and breakfast meetings—will be announced soon.
About ProductLife Group
ProductLife Group is a trusted partner that helps clients stay ahead of the changing R&D landscape.
We provide support across all stages of the product life cycle and have experience in working with companies in all segments of the life sciences industry.
With an established presence in five European countries, extensive capabilities in key markets, and more than two decades of serving the industry, ProductLife Group has a solid platform from which to provide clients a range of services, consulting, and outsourcing solutions. We empower clients to focus
on innovation and business growth strategies and to make strong, informed decisions every step of the way. What’s more, we wrap it all up with partnership flexibility, for a truly custom experience that helps clients scale their initiatives cost-effectively.
By leveraging the power of deep domain expertise, relationships, collaboration, and a flexible delivery framework, ProductLife Group delivers exceptional service to clients. Our goal is to develop long-term relationships by being responsive and relevant and by consistently delivering value. We cultivate a trusting, consultative environment and are positioned to operate as an extension of clients’ businesses, with a shared interest in their long-term success.
More at ProductLife Group or follow us on Twitter at @ProductLife_EU.
Sarum PR – PR for ProductLife Group
+44 1722 322916
Tags: ProductLife Group, PLG, life sciences, regulatory IM, reg IM, Merck Serono, PLG Evolve,
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