An interview with the Director, Strategy Implementation Leader Biopharma | R&D Strategy and Business Operations, IDMP Project Lead of Merck
Ahead of the 4th Edition IDMP Compliance Challenge: Navigating through uncertainty Conference, we spoke with Dr. Andrea Herrmann MDRA, Director, Strategy Implementation Leader Biopharma | R&D Strategy and Business Operations, IDMP Project Lead at Merck KGaA about how pharma companies can progress with the new regulation.
How can pharma companies progress with the new regulation?
While some pharma companies focusing primary on fulfilling compliance standards, Merck is going one step further and is using the IDMP initiative to “go beyond compliance”.
Using this opportunity, pharma companies can highly benefit from IDMP and drive their internal digitalization; streamlining their processes landscape, data standards and IT architecture – one potential goal can be here the creation and establishment of a master data management system. By replacing manual paperwork with software, companies can use this flexibility to react quicker on updates of compliance requirements from authorities.
In addition, companies will be able to automatically gain information on their internal processes, data quality and managing their causes of risks. This new fact based capabilities can be used to improve patient services, enabled by a granular level of product traceability. Furthermore, business processes can be optimized as the improved data availability and quality can be used to drive initiatives to increase operational efficiency.
What are the challenges involved in the IDMP Project Change Management?
When it comes to the challenges of Change Management, it is important to understand that the IDMP project will impact a broad range of stakeholders along the entire value chain within the upcoming years. Starting with the focus on organizational data and growing over time with focus on product and substance information. In
addition, many details of IDMP are not yet finally decided and therefore not yet communicated and it will be defined by authorities in the
upcoming future. This impacts our ability to gain buy-in from team members and to give commitment to the stakeholders within the organization.
Considering these challenges, we have defined an engagement approach that is changing over time to fulfill the information needs of our stakeholders. The main idea of this approach is to include all project participants (beyond iteration 1) at a very early stage of the project. We are providing them with the progress of the IDMP Project on a frequent basis, even though their full participation will take place in several months in the future. In addition, stakeholders are informed on their expected date of engagement, helping them to prepare accordingly when higher level of attention is required.
Functions with deep project involvement are engaged directly via tailored roadshows. IDMP ambassadors are announced and trained to prepare each function on their upcoming roles and responsibilities to support the implementation of the project.
How would you advice companies to prepare for IDMP as a Long-Term Information Management Project?
Companies planning to implement the IDMP standard within their organization will need to keep up with the momentum over a long period in an evolving environment.
To manage this level of change, it is important to focus on areas that can be controlled by the company itself. In regards to IDMP, companies can focus on Master Data Management (MDM) as a significant milestone to drive the organization beyond compliance. Being able to manage its master data is an important capability that is required for IDMP, as well as for company’s operational requirements to provide additional business benefits. Changes within the organization range here from process changes up to the implementation of new IT systems and data cleansing.
To support stakeholders in the decision process within the project it is essential to build a culture of trust that deals with the evolving arena of IDMP. Associated there with, it is important to clearly communicate to stakeholders those decisions and definitions can change over time, as new information from authorities and updates of decisions are part of the project. The aimed business benefits of the project can be used as a beacon to give stakeholders orientation within their decision processes to define new processes, data standards, or adaption in their IT systems.
Furthermore, the early implementation of an “IDMP Office” is essential to manage the governance and maintenance of the IDMP Master Data. The office should be
designed as a network of IDMP Officers from several functions, who can support the organization as a single point of contact for IDMP related questions. Feedback initiated by authorities after submission can also be bundled and monitored by the IDMP Office, ensuring that these changes are sustainably implemented within the company.
Another point that should be mentioned deals with the preparation of the organization for new requirements. As insights in processes, medicinal products, organizational data, and substances will grow over time, the ability to interpret this insight will become more and more important. Training or hiring of Data Managers with analytical capabilities will therefore be essential to use the newly available insights provided by IDMP, or combine
them with other data available within the company.
Last but not least, companies should focus on a scalable IT landscape that is able to grow with the IDMP standard over time and can also be leveraged with additional initiatives required for authorities outside of Europe.
What would you like to achieve by attending the 4th Edition Impact of the Fundamental Review of the Trading Book Conference?
One of my major goals is to get in touch with industry representatives, in order to share my so far gained experience of the IDMP project at Merck. In addition, I am very curious how other professionals have engaged the IDMP project within their company and how they organized the project to keep up the momentum, staying flexible to react on upcoming changes from authorities.
About the speaker:
While working at Merck, she first did her Master of Drug Regulatory Affairs at DGRA (“Deutsche Gesellschaft für Drug Regulatory Affairs”) in Bonn and afterwards she did her doctor of science at the University of Bonn in the field “Regulatory Affairs”.
Besides the science based trainings she attended over several years different coaching trainings and did a 2 years coaching education.
Within GRA, she held different positions, she was within Regulatory International responsible for the dossier updates for the new EU member states in 2004 and in 2007, responsible for all regulatory activities in Russia &CIS and South Eastern Europe, and then she took the lead to build up regulatory strategy for international countries for late stage and early stage oncology products. She has experience in registration of chemical and biological products worldwide. She also worked as a team lead and group head for coordinating and guidance of all regulatory activities for certain international regions. As a marketed product leader she was the strategic pillar for all regulatory activities for fertility products worldwide. Since April 2016 she is leading the IDMP project as Strategic Implementation Leader within Strategy and Business Operations.
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What are the challenges involved in the IDMP Project Change Management?