The first two webinars in AMPLEXOR Life Sciences 2019 webinar program have been announced, focusing on Regulatory Information Management (RIM): Delivering Better Efficiencies Across Operations and Ensuring Compliance for Pharma Companies Through Local Label Deviations.
The first webinar “ Regulatory Information Management (RIM): Delivering Better Efficiencies Across Operations “ takes place on 26 February. Frits Stulp, Managing Director, Iperion Life Sciences Consultancy, will explore how automation, which used to mainly be about standardizing your way of working in such ways that manual processes could be replaced by machines, has now matured to the point where informed decision-making based on high-quality data lies within reach.
He will also show how the introduction of product information data standards, such as IDMP, a new generation of RIM systems and better integration of information flows, enables organizations to provide the right information to the right people at the right time so they can make the right decisions. In this webinar, Frits will provide you with valuable insights on where he believes the industry is going and offer recommendation on how you should get started “ all based on best practices and real-life experiences.
The second webinar “ Ensuring Compliance for Pharma Companies Through Local Label Deviations “ takes place on 28 February. Kathleen OBrien, Director, Business Development, AMPLEXOR Life Sciences, will present a guide to avoiding regulatory trouble with the Health Authorities. She will argue that many global pharmaceutical companies are now faced with a volume of content in the field that has grown to a point where the quality of that labeling is unknown. Assessment of what exists and correcting the process to avoid pitfalls in the future can therefore be a daunting task.
In this session, Kathleen will review a retrospective labeling case study that not only provided data to identify deviations in local labeling, but also shed some light on the path forward. In addition, AMPLEXORs David Gwyn, Global Solution Architect, will share an overview of options to ensure compliance by leveraging the AMPLEXOR Life Sciences Suite.
The Regulatory Information Management (RIM): Delivering Better Efficiencies Across Operations webinar will take place on 26 February 2019: Session A: 10 a.m. EST and Session B: 1 p.m. EST. To register for this webinar, click here.
The Ensuring Compliance for Pharma Companies Through Local Label Deviations webinar takes place on 28 February 2019 at 1 p.m. EST. To register for this webinar, click here.
About the Presenter
Frits Stulp, Managing Director, Iperion Life Sciences Consultancy Frits Stulp is the managing director of Iperion Life Sciences Consultancy and IDMP SME. He has more than 18 years of experience in the Life Sciences industry. As a project manager, he specialized in the management of IT projects for regulatory compliance and has been the program manager of the first completed IDMP implementation program. Frits serves several clients as IDMP program advisor. He has been a member of the EMA ISO IDMP Task Force and is an active promoter of IDMP at conferences and webinars.
Kathleen OBrien, Director, Business Development “ AMPLEXOR Life Sciences Kathleen OBrien is director of business development with AMPLEXOR Life Sciences and a 15-year veteran of the translation industry. Kathleen has a background in linguistics and has held various roles in the translation business: vendor, project and account management, as well as new business development, giving her a unique perspective into both translation operations and how translation impacts the globalization needs of her clients in the pharmaceutical and medical device industries. She proactively collaborates with her life sciences client partners on a daily basis to help them set their localization strategies.
David Gwyn, Global Solutions Architect “ AMPLEXOR Life Sciences With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience delivering solutions to customers, with a particular focus in the areas of regulatory information management (RIM), content management and collaboration. As a global solution architect for AMPLEXOR Life Sciences, his main focus is aligning customer needs with the capabilities of the companys Life Sciences Suite and ensure that the solution meets the needs of the customer. He also leads the DIA EDM Submission Reference Model team that developed a document architecture for use when designing and building content management solutions.
About AMPLEXOR Life Sciences
AMPLEXOR Life Sciences assists organizations developing pharmaceuticals, medical devices, and biotechnology with launching products and breaking into new markets quickly. Our proven solutions as well as professional and business services expedite the creation and delivery of consistent, compliant, high-quality and global content “ both physical and digital.
AMPLEXOR Life Sciences boasts a rich 25+ year history of serving pharmaceutical producers, medical device manufacturers, and biotechnology companies.
For more information, go to www.amplexor.com/lifesciences.
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