Webinar Series - IDMP Process Management - Celegence

Building a Flexible and Future-Proof IDMP Data & Process Management Strategy

Webinar Background

For several companies, the announcement of the EMA that the DADI project will be the main focus for regulatory data submissions has meant that they needed to revisit/realign their IDMP implementation projects once again. But is/was this really needed and if so, how can this be avoided going forward?

It cannot be denied, that the approach needed to achieve compliance is shifting continuously but at the same time it is important to realize that the underlying ISO-IDMP structure remains the same. The benefits that  implementation of ISO-IDMP brings to the life science industry remain the same. As such it is important that your implementation strategy is not only focused around achieving compliance, but that it also keeps in mind the internal improvements in data quality and processes, the implementation of the ISO-IDMP standard can bring. Achieving compliance should be an important part of your strategy, but your strategy should not be controlled by compliance only.

Join us to hear from the perspective of our Identification of Medicinal Products (IDMP) subject matter expert, Wim Cypers.

In this 3 part series, we will be focusing on three important aspects of an effective ISO-IDMP implementation within your organization.

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EU MDR - Celegence Life Science

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Webinar Featured Presenter

Wim Cypers has a long-standing experience in converting business requirements into application functionality and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues.

  • Before becoming an independent consultant for Celegence, Wim was employed by ArisGlobal for more than 26 years where at the end he defined the company’s product and platform strategy.
  • Before this role he also managed the product management function for both the safety and regulatory solutions. Early in his career he was responsible for the successful implementation of the regulatory and safety solution at some of ArisGlobal main customers.
  • Until 2021, Wim was a member of the EMA IDMP task force and currently remains up to speed with the IDMP topic and the key benefits it can bring to the industry.
  • Before joining ArisGlobal, Wim worked for 2 years at Janssen Research Foundation in Belgium as project leader for the development and deployment of their regulatory tracking solution.
  • Wim holds a degree as industrial pharmacist from the Katholieke Universiteit Leuven, Belgium. With a passion for spaceflight, he works out of Beerse, Belgium where he lives with his family.
Wim Cypers - IDMP Webinar Presenter -Celegence

Webinar: Building a Flexible and Future Proof IDMP Data & Process Management Strategy

Part 1: Data Management

Celegence will be hosting this WEBINAR on June 14th at 10 am EST. Register Now for Part 1

In this session we will focus on the data which is needed to be compliant but also address challenges and tips which can help build or improve your IDMP repository. How to leverage  internal and external sources of data, the importance of alignment of data, and technical considerations. The session will also address how you can manage your IDMP data in a way that will align regulatory, IDMP and Compliance needs and more importantly limit the impact of changing external influences.

Future Proof IDMP Data Management - June 14 - Celegence

Part 2: Process Optimization
Celegence will be hosting this WEBINAR on June 21st at 10 am EST. Register Now for Part 2

In this session, we will be looking at both external (compliance) and internal-facing processes’. How do you best address the phased DADI approach and how do you align this with the need to keep the xEVMPD submissions going in parallel. What is needed internally to ensure that data is shared within your organization at the appropriate time and how do you build processes which ensure data is not only shared but also stays in sync over time.

Future Proof IDMP - Process Optimization - June 21 - Celegence

Part 3: Cross Department Benefits
Celegence will be hosting this WEBINAR on June 28th at 10 am EST. Register Now for Part 3

In this last session we will be focusing on some specific use cases where IDMP can play a key role. We will look at possible integration points with safety, manufacturing and clinical. How can the integration be achieved, what elements are needed and how can you ensure the approach is extendable.

Future Proof IDMP - Cross Department Benefits - June 28 - Celegence

Webinar Learning Objectives

  • Discussion of how you can manage your IDMP data in a way that will align regulatory, IDMP and compliance needs.
  • Explanations on how to best address the phased DADI approach
  • Explore the potential integrations with other regulatory process areas/functions to help identify and extract the data you need
  • Practical Examples and Case Studies
  • Q/A session with our expert panellist

Who Should Attend?

This webinar would support those working for companies in the life sciences, including pharmaceutical companies, with a special emphasis on:

  • Quality and Regulatory
  • Product Development and Manufacturing
  • Engineering and Operations
  • Quality Assurance
  • Research & Development
EU MDR - Checklist - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW
EU MDR - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW

Celegence – Services and Solutions to Support the Life Sciences

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing, and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you through the webinar and hope that you can join us then.

For more information on how Celegence can help with Learning Management, reach out to us at info@celegence.com or contact us online