Issue link: https://www.e-digitaleditions.com/i/1462272
www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 21 a considerable benef it to companies, agencies, and, therefore, ultimately to patients, getting ready for IDMP is not straightforward. Stulp (Iperion): It is expected that IDMP data standards will be imple- mented as par t of the SPOR pro- gramme, which will be used directly by the Digital Application Dataset Integration (DADI) project. Existing electronic application forms (eAFs) will be replaced by this project. This will trigger a huge step forward in the submission of structured data within the regulatory processes. This change requires companies to control their regulatory data in accor- dance with the ISO IDMP standards and controlled vocabularies. POTENTIAL HURDLES BioPharm: What, in your opinion, could be signif icant bottlenecks for bio/pharma companies in the future in terms of data and documents? Munnik (Iperion): ISO IDMP requires data from different depart- ments. For this reason, data gover- na nce — c lea r r u les on r ights a nd accountabilities for the data—must be considered and provided for. Due to the tie-in of the submission of struc- tured regulatory data and the regu- lator y process, companies need to have processes and systems in place to access structured data from the get-go. Authors contributing to the support- ing documents for product registration will need direct access to the latest and agreed terms to ensure consistent use. Although this may sound chal- lenging, this requirement provides an opportunity to control the regulatory data end-to-end—from development and across the regulatory process and pharmacovigilance—and achieve ben- efits (e.g., cross-divisional reporting), harnessing that data as the definitive source for authoring. Kelleher (Generis): Much of the data required is, of course, already present within company databases— but frequently in multiple databases, which have different data owners and stewards, and are not linked or syn- chronised. Additionally, data [are] quite often in the wrong format—one key example being items such as dosage strength, where some companies might have a dosage strength as a single value ('10 mg/100 mL') and others might have four data items ('10', 'milligrams', '100', 'millilitres'). These data items might even be free text in some systems inter- nally, leading to a need for a substantial exercise in data cleaning/consolidation. As companies look to do business in Europe and meet these standards, they will also f ind t wo basic t y pes of vendors on the market: those who provide a dedicated IDMP database (yet a not her database of sepa rate information), meaning users have to enter data that is potentially dupli- cated in other systems, and poten- tia l ly in different formats and not linked to the regulator y documents and applications/registrations; and those who provide regulatory systems where the data [a re] capt ured and applied, in the right format, to docu- ments and submissions as part of the regulatory operations processes, and can then be compiled /extracted to provide the required IDMP submis- sions, without duplication. INCREASED DIGITALIZATION BioPharm: Do you believe there will be an increased demand for digital pro- visions post-pandemic, and if so, how might this impact the volume of data to be processed by companies? Kelleher (Generis): The use of digital /virtual solutions will abso- lutely increase—having been forced to accelerate the implementation of such capabilities during the pandemic, com- panies are really seeing the benefits in both the speed with which they can perform business processes (and there- fore being able to do more in the same time) as well as the consistency of data that it brings, improving compliance, reducing rework and errors. One emerging trend is the desire to increase automations—having a sys- tem that acts as a 'dump' of data or documents is no longer sufficient, and companies are looking at systems that have capabilities to automate repet- itive processes into a single button click. One great example is around the audits and inspections: prev i- ously, setting up an audit, requesting particular documents ahead of time, choosing dates, receiving pre-audit documents, and so on, was all done back and for th by emails. Now, a single audit object can be created which automates the process of noti- f ications, uploads of documents, set- ting of meetings, and also generating a final audit report. Stulp (Iperion): Digitalization is the future—to optimize existing pro- cesses and data f lows. With increased demands as well as expectations around healthcare, the competent authorities will need to be able to do more with the same resources. It's essential, then, to be able to leverage the potential of digital data/processes. This can only be achieved by adopting standards. The use of standardized and structured data will not only ensure data quality and consistency; it will also help accelerate regulatory processing and assessment by the health authorities. The sky is the limit, and the time is right to shape the future. What's more, society will expect no less. Quality and Regulatory Sourcebook Regulations: Data Integrity "Most companies are still struggling with the legacy of data captured and held in documents." —Remco Munik, Iperion Life Sciences