IDMP Webinar Series - Part 1: Data Management

Описание: Celegence (https://www.celegence.com/) provides the pharmaceutical industry with consulting services that are tailored to the evolving operational and strategic needs of manufacturers in areas such as RIMS data management, publishing, and medical writing.

This webinar (Part 1) is to best understand the important aspect of an effective ISO-IDMP implementation within your organization – Data Management and how to achieve effective regulatory compliance.

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?

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:

1. Data Management
2. Process Optimization
3. Cross Department Benefits

In this webinar (Part 1) 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. This webinar 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.

Celegence has built an IDMP transition and implementation framework focusing not only on achieving compliance but also ensuring additional benefits for the regulatory department and across your organization. Our team of technical and regulatory consultants can provide you with an in-depth analysis of your existing processes and technologies and create an accurate assessment of the changes your organization needs to ensure IDMP compliance. To know more reach out to us at [email protected], or read more about Celegence’s IDMP services - https://www.celegence.com/services/id...