IDMP supports the core missions of industry and regulators, which is grounded upon the premise that each plays a vital role in promoting and protecting public health. The external relationships and information obtained from healthcare providers and patients help complete the co-dependent ecosystem of life science, which is used to inform and impact clinical research and regulatory decisions throughout the product development life cycle. The success of the ecosystem is dependent upon the availability and exchange of high-quality and reliable data about the composition, safety, effectiveness and distribution of products used in healthcare.
The WHO identified ten threats to global health which essentially help provide a road map for industry to focus its attention for new or improved drug development. A review of the top 10 drugs (based upon revenue) support the WHO’s findings about the effects of noncommunicable diseases, which account for over 70% of all deaths worldwide. The healthcare system is further strained by an increasing demand for products and services designed to mitigate the effects of an ageing population.
IDMP helps to support the challenges and opportunities for meeting the demands of the life science ecosystem by:
- Providing a robust structure and framework for creating and maintaining high-quality and reliable drug and medical device data resources used for managing regulatory submissions and product-related information exchanges with industry partners (e.g., CROs, co-manufacturers)
- Providing a consistent and internationally harmonized structure for representing the scientific and manufacturing content used as a basis to support regulatory review and approval, which serves as the input into the healthcare process
- Providing structures, terms and identifiers to accurately identify substances and products used in clinical trials and healthcare. Patients and healthcare providers need assurance that the information they have is based upon an authoritative source of truth
- Providing terms and identifiers to support consistent and reliable exchange of product information used for downstream healthcare processes such as prescription, dispense, administration and monitoring of the safety and efficacy of products used in healthcare
- Providing an accurate representation and assurance of the availability of products within the supply chain, which helps to mitigate public health threats associated with drug shortages, contamination, counterfeits or the proliferation of unlicensed or unsafe products
This is not a regulatory compliance problem.
The success of IDMP is dependent upon building strong and committed partnerships between the pharmaceutical industry, global regulators and health IT vendors to provide the required leadership, tools and services to make IDMP a reality. No one organization can do it alone and Iperion is dedicated to the life sciences industry by providing the expertise, systems and tools that help sustain and support the ecosystem. I decided to join Iperion because as a health scientist, I am concerned about the threats to patient safety and public health. I have been among the cohort of individuals around the world that do not have adequate access to healthcare or suffered side affects of medication that according to the latest science, was no longer considered the best therapy for me. Healthcare practitioners do not have the luxury to constantly read and research advances in drug therapy and often default to a path of least resistance instead of fighting with US heath insurance companies. This is not a regulatory compliance problem.
Iperion is committed to providing leadership, services and tools to help support industry and regulator efforts to transform and improve their infrastructure to create high quality outputs (drug approvals, labeling, promotional materials and AE data sets) that serve as inputs into the healthcare system. We remember why we are here.
We support the global healthcare ecosystem by reminding everyone that our collective IDMP work is designed to help empower patients. Patients need and deserve access to reliable and accurate information about the products they use to help them manage and support their health and wellness goals. Healthcare providers need access to the latest clinical research, real work evidence and advances in medical technology to help them make informed decisions.
Let us work in committed partnership to move the global healthcare system forward. Let us pool our resources and expertise to tackle the challenges and opportunities that IDMP adoption offers us to create high quality information resources and data sets. Let us help empower physicians and patients with quality information about the products they use. Iperion is answering the call – won’t you join us?
Otherwise, why are you here?
My name is Lise Stevens. I am currently serving as Associate Director for regulatory information management and pharmacovigilance at Iperion in the US. My personal philosophy is deeply rooted in the belief that good health and overall well-being is a basic human right and collectively healthcare providers, regulators, bio/pharmaceutical companies and health IT vendors equally share in the responsibility to protect and promote public health – especially in underserved or under-represented populations. In addition to this, am I a Certified Ayurvedic Wellness Counselor.