The health care scenario is highly regulated and with intrinsic complexities that require a team of experts, who have vast experience working in the health care continuum, involving regulatory agencies. A proactive approach is used for regulatory compliance that supports audit-ready documentation.
Despite the global challenges posed by the COVID-19 pandemic in 2020, Navitas Life Sciences continued to forge ahead with the sole purpose of assisting small to large pharmaceutical companies to gain regulatory approval for their drug products. Experts at Navitas Life Sciences provide the necessary guidance that will help life saving drugs improve the health of patients who most need them.
Evolving regulatory environment
With Britain leaving the European Union, the Identification of Medicinal Products (IDMP) is a crucial regulatory compliance challenge that pharmaceutical companies functioning in Europe would have to face.
The move towards IDMP compliance is an assertive move towards better patient safety and improved business transformation.
IDMP is becoming Mandatory – A Roadmap to Compliance
If you are interested in learning more, join our live webinar to be conducted by experts Gary Wilson and Varadarajan Srinivasan
Date: Thursday 01 July | 10:00 – 11:00 EST and 16:00 – 17:00 CEST
Duration: 1 hour
What is IDMP?
IDMP regulation consists of base standards that are required to identify medicinal products uniquely. This would facilitate product information standardization and aid in providing consistent information exchange between pharmaceutical companies and global regulators, with the sole purpose of improving patient safety.
IDMP compliance is fast approaching and key insights about the compliance pathway and steps to be taken are provided in a webinar hosted by Mr. Gary Wilson, Director at CorrIT and Mr. Raj Srinivasan, Executive Business Partner - Safety and Regulatory Technology – EMEA & APAC at Navitas Life Sciences.
Gary (GW) and Raj (VS) took time off from their busy schedules to answer a few questions, throwing light on the strategic IDMP compliance pathway.
Tell us a bit about your professional background
GW: I am the Managing Director at CorrIT and creator of the SPORIFY. I have 18 years IT industry and consultancy experience.
Since the launch of SPORIFY in 2017, CorrIT has assisted many organizations and regulators with their implementation and integration of SPOR and other externally hosted Master Data Services. I am a member of the SPOR Industry key user group and regularly advise EMA and the SPOR task force on topics related to SPOR technical implementation.
VS: I am VP – Business Partner at Navitas Life Sciences. I have over 15 years of experience in driving innovations in safety and regulatory technology and am an expert in regulatory technology – RIMS, eCTD, DMS, QMS, ERP and PV. I have worked on several solutions including end-to-end-safety that delivers immense value to emerging and mid-size pharma companies, playing the role of trusted technology advisor to several leading pharma cos across the globe
Is the IDMP compliance already a mandate? How does it help the industry?
GW: IDMP is an international standard defined by the international standards organization (ISO). IDMP standards and technical specifications, comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844, support the activities of medicines agencies worldwide. In Europe, EMA are in the process of implementing ISO IDMP as Europe moves to a structured data approach to medicines regulation. SPOR is a set of controlled vocabularies for 4 domains of master data used in ISO IDMP (Substance, Product, Organization, References) and forms the foundation for IT systems that will populate and IDMP compliant dataset to transfer data between industry and NCAs in Europe once we go live in 2023. This move towards structured data will improve Data Quality as well as streamline data creation and processing eventually leading to interconnected systems always up to date with the latest information.
Beyond EMA, are other regulatory authorities gearing up for similar compliance requirements?
GW: EMA are leading the way in IDMP with the implementation in Europe but other authorities around the world are also moving towards this new IDMP approach to structured data. In the USA for example the PQ/CMC and KASA initiatives will make use of standard PQ/CMC terminologies in a similar way to how SPOR provides standard terminologies in Europe and as recently as 14th June Health Canada has also published their list of controlled vocabularies for use in Canada.
Why is managing regulatory information a complex activity?
VS: Information resides in silos and lacks well-defined data governance, data versioning and data management approach. This makes cross functional collaboration a nightmare.
How is pharma industry progressing towards achieving RIM maturity?
VS: The pharma industry is defining various processes that support the product life cycle and identifying golden sources for various product information. It is adapting a master data management approach to get integrated RIM data right
Do you have matured solutions to support industry in achieving RIM maturity and IDMP compliance?
GW: Yes, indeed. SPORIFY has been on the market since 2017 and since then we have worked with over half of the European NCAs to assist them aligning their internal data to SPOR data. We also work with Industry and SPORIFY helps pharma companies of all sizes every day align their internal data to SPOR and G-SRS data.
We have a flexible and scalable solution to support the needs of companies of all sizes and our customers today include over 10 European Regulators, 3 of the top 5 pharma companies in the world as well as 3 of the top 5 animal health companies in the world.
VS: Yes, our rimREADY solution enables comprehensive regulatory information management covering key processes such as Submissions Planning, Registration Management, Dossier Management, Compliance Management and Change Request Management. This solution readily integrates with various applications like eCTD, DMS, QMS, PV systems etc. for well-orchestrated RIM processes
The implementation of IDMP will aid in the unique identification of medicinal products, thereby improving pharmacovigilance. It will improve the quality of data sets used globally. It will also aid in improved communication between regulatory bodies and pharmaceutical companies.
IDMP compliance will also help in streamlining site data, thereby ensuring Good Manufacturing Practice (GMP) and improving assessments of drug products in clinical trials.