With the ongoing IDMP implementations throughout the world everyone is getting ready for data submissions.
One of the parts of IDMP, Substances, is usually a smaller focus point during the implementation projects. We thoroughly believe substances are important and stand at the basis of everything within the Pharma industry. We are organizing a webinar on Substance Management on Monday 25 May 2020, because we have a strong drive to make a difference and we are reaching out and help you in your next steps regarding your data, including Substance information. This information is used in all parts of an organization, but how can you be sure all parts are aligned? Good substance information management can be a great benefit for your organization. This webinar will consist of a presentation detailing the above with some additional time to discuss questions on substance management.
Substance management: Do I need all this detail?
Substances are the most vital components contained in and used to define each pharmaceutical product. Good, accurate and unique substance identification is paramount, both for the active ingredient(s) as well as excipients. Within the ISO IDMP standards and guidance an extensive data model has been developed suitable for the data description of every specific defining element of a substance. Describing your substance in data can streamline your processes, improve traceability of substances and their roles in products, and facilitate batch registration. All leading to greater control over your substance and product information (e.g. batch recalls, manufacturer compliance issues, etc.).
Substance management is about the identification of substances within pharmaceutical products and the consistent use of the same information throughout the life cycle of your products. This includes but is not limited to regulatory processes, research and manufacturing and control processes.
What can you expect?
In this webinar we want to inform you about key principles regarding Substance Management such as:
- The importance of good substance information management based on several use cases
- The benefits of using substance master data
- The progress the authorities are making on substance management, including EU-SRS
- Preparations you can make for substance submissions and EU-SRS in the future
- Conclusions and recommended practical next steps
Hosted by Frits Stulp and Camiel Hoogendoorn
Your hosts during this webinar are Frits Stulp, managing director and Camiel Hoogendoorn, consultant of Iperion Life Sciences Consultancy.
Frits Stulp has 20+ years of industry and consultancy experience. Frits acts as an Identification of Medicinal Products (IDMP) subject matter expert and program manager for several Marketing Authorization Holders. He also serves as an Implementation of Regulatory Submission Standards IDMP Topic Group Lead. Frits has experience serving as an EU-SRS project manager for Medicines Evaluation Board.
Camiel Hoogendoorn has been a consultant with experience in Life Science and Regulatory affairs, labeling and IDMP. He is an SME for Substance Information Management and ISO IDMP and a project member of EU-SRS as a business analyst. Camiel is a member of the ISO/TC 215 WG6 Pharmacy business, working on the IDMP standard. As a consultant he had multiple roles in IDMP assessments and trainings, as well as labeling process optimization (MAH).