Dowload our webinar to learn more about Substance Information Management.
For many pharmaceutical companies, there is a daunting task ahead to align and maintain substance data throughout the company. During this webinar we will present our experience on substance management, and we share the challenges we have seen in various companies.
During this webinar you will learn
- The latest update on global regulatory developments and impact on your substance management
- What good substance information management is and why it is important
- The 3 aspects of Substance Information management: Compliance, Process alignment and Data Management and dive deeper into how these can be achieved.
Good substance information serves as the foundation for product information throughout the life cycle of your products. For good robust substance information to be available at all lifecycle stages it is important to have a good grip on the processes generating and exchanging this information. Process alignment
To be compliant is “easy” as very often the concept of a substance is reduced to a single term or identifier. Aligning these is to be compliant. We believe, however, that it is important to truly understand the underlying process creating the substance information. Throughout the substance lifecycle a substance may have many names and codes associated with it, do you know where they all originate? And more importantly, do all names actually align to the same substance? Data management
Once you have identified and aligned your process from the first moment of discovery to the sunset clause you can continue with the alignment of data throughout this process. Substance information is relevant throughout the lifecycle of a product, having reliable data on it even more so.
By identifying where information for substances is created and consumed, the format of that information and exchange you can create a map of processes and systems that define substances for your company. This map can be used to streamline information, define ownership and responsibilities and provide a common language for you internally and internationally.
This webinar is hosted by our Substance experts Camiel Hoogendoorn and Sara Fidalgo. Camiel Hoogendoorn
is a Junior Manager at Iperion a Deloitte business with a lifelong interest in biology and chemicals and almost a decade of experience with IDMP, focusing on IDMP substances. Sara Fidalgo
is a Manager at Iperion- a Deloitte business with over 13 years of experience in Life Sciences, within academic research environment and as a consultant with experience as an SME for ISO IDMP standards for both medicinal product and substance information.