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MAPI GROUP
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  • Pharmacovigilance Legislation: The Impact of What Is Happening in Europe

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About the Company
Mapi is the leading Patient-Centered Research company serving academia, life science researchers, and the pharmaceutical industry for over 40 years. Mapi’s commitment to patient-focused research is demonstrated not only by our expertise and nearly four decades of service but also through our direct contribution back to the industry. Mapi is among only a handful of global organizations that is capable of engaging with a patie...
Mapi is the leading Patient-Centered Research company serving academia, life science researchers, and the pharmaceutical industry for over 40 years. Mapi’s commitment to patient-focused research is demonstrated not only by our expertise and nearly four decades of service but also through our direct contribution back to the industry. Mapi is among only a handful of global organizations that is capable of engaging with a patients’ complete ecosystem, their HCPs, Patient Communities, payers, and even regulators. And only Mapi has the unique history to make us the most experienced at interacting with all of them. Mapi was founded in 1974 and was focused on the patient from the very beginning. With our Real-World Evidence and post-approval research services, consulting expertise, and publications to our not-for-profit entity, Mapi has been the leading industry driver toward patient-centered research for nearly four decades. Mapi has donated and re-invested millions of euro to improve life science research and development, as well as establish the patient as the center of clinical research. These investments include: intellectual property services; funding to establish industry working groups with regulatory bodies, including the ERIQA project and the PRO Harmonization initiative; subsidizing academic researchers and founding the Mapi Research Trust, a non-profit center for curating Clinical Outcome Assessments. During our decades of Patient-Centered Research history, we’ve seen an industry eager to embrace patient insight. From the mid-1970s to the early 1980s, the promise of faster and cheaper research forced many companies to only invest in the data needed to satisfy safety and efficacy, leaving patient insight for post-approval research as an afterthought to drug approval. Unfortunately many companies still have this view today. We have also seen non-governmental agencies such as health technology assessers, accountable care organizations, patient advocacy groups, key opinion leaders, and even healthcare payers rely on the foundations Mapi helped establish. These foundations include: the establishment of the concepts and methodology behind Linguistic Validation, leading to Mapi completing over 35,000 international versions of 2,300 instruments; Mapi’s leadership in support of Post-Approval Epidemiology and REMS/RMP programs; and the Pro-Harmonization initiative, which allowed us to proactively affect the regulatory environment.
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Mapi Group
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UNITED STATES
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2343 Alexandria Drive, Suite 100 Lexington, KY 40504
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+1 859 223 4334
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  • Pharmacovigilance Legislation: The Impact of What Is Happening in Europe
  • Priority PASS

https://www.pharmacompass.com/jAssets/pdf/party/content/Mapi-Group-party-content-1498548122.pdf

https://www.pharmacompass.com/jAssets/pdf/party/content/Mapi-Group-party-content-1498548193.pdf

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