About the webinar

The webinar will be run fully from a Virtual Reality space and will try to inspire the audience with the capabilities of this technology and will try in an illustrative way to explain the IDMP concept. We will build the IDMP cactus in one place, using objects from the IDMP repository.

We will try to reflect the “Example 1: Losec Control 20mg gastro-resistant tablets” based on EMA’s “Annex I – Complete representation, Annex to EU IG Chapter 8 – Practical examples”.

Walk the repository – imagine not just the data model, and visualization of Medicinal Product as a cactus. Imagine combining Regulatory Information Data with Regulatory Intelligence Data, Manufacturing Data, ERP Data and Marketing Data and represent it visually and virtually in 3D to make better business decisions.

So yes, IDMP can be a cactus.

About the speaker

Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.

About the webinar

Learn why traditional production tools and processes come up short for content authoring and how you can combat this, while keeping up with regulatory changes, increase in content volume and time-to-market acceleration.

About the speakers

Pepijn Mul is ECM Consultant at Amplexor. With over 10 years of experience in software development, technical writing and industrial design, Pepijn has a successful track record in translating complex technical subjects to logical models. At Amplexor, he drives content innovation for our clients with tailored documentation authoring solutions.

Kathleen O’Brien 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.

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About the speaker

As Director of Products, Renato is responsible for Amplexor’s Life Sciences Product Management. He has thirteen years of experience in analyzing, designing and implementing end-to-end regulatory solutions for the Life Sciences industry. In his first nine years at Amplexor, Renato managed several implementations of integral regulatory and quality management solutions for global pharmaceutical companies as well as health authorities. Over the past four years, Renato established the Product Management organization that focuses on innovation, compliance, and quality of its product portfolio. Renato has a bachelor’s degree in Computer and Information Science from Ljubljana University.

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Agnes’ main responsibilities are the provision of business and compliance requirements for the Amplexor Life Sciences Suite, the supervision of the Life Sciences Consultants and the delivery of process and data management expertise to Amplexor clients in Regulatory Information Management, including Document Management, Submission Management and Labeling Management.

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With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for Amplexor Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.

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Watch our webinar for tips on how to improve adaptability through RIM systems.

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With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for Amplexor Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.