Brand Institute Announces Highest Mid-Year Success Rate for EMA Brand Name Approvals in Company's History
13 Jul 2022
Nakos Balamotis, BSc, PharmD, applies his first-hand knowledge of EMA's unique name review process to a rigorous safety evaluation of drug names
MIAMI, July 13, 2022 /PRNewswire/ -- Brand Institute, the global leader in pharmaceutical and healthcare related name development, is pleased to announce the highest mid-year success rate for European Medicines Agency (EMA) brand name approvals in Brand Institute's history. Having obtained feedback from three Name Review Group meetings in 2022, Brand Institute has had a remarkable outcome for names submitted, especially with names ranked as 'low risk' during Brand Institute's internal assessment.
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Source: PRNewswire
Nakos Balamotis, BSc, PharmD President, EU Regulatory Affairs
Brand Institute's 'DSI Name Research Methodology' is based on global guidance on name assessment. Its EU division is led by Nakos Balamotis, President, EU Regulatory Affairs for Brand Institute's regulatory subsidiary, Drug Safety Institute (DSI).
Before joining DSI, Dr. Balamotis was part of the EMA's Name Review Group. During his time with EMA, Dr. Balamotis reported directly to EMA's NRG Secretariat and participated in all NRG meetings, communicating outcomes with NRG affiliates. He also assisted the EMA in conducting technical reviews of product information and was involved in the implementation of the Pharmacovigilance legislation.
At Brand Institute, Dr. Balamotis oversees all global safety research conducted on proprietary drug names, applying regulatory considerations unique to the name review process of Health Regulators. During his 8-year tenure with DSI, Dr Balamotis has contributed to the evaluation of more than 13,000 brand names for the European market and the implementation of effective evaluation methodology.
Dr. Balamotis earned his Doctor of Pharmacy from Carlo Bo University of Urbino, Italy and a BSc in Chemistry at Aristotle University of Thessaloniki, Greece.
About Brand Institute and its wholly owned subsidiary, Drug Safety Institute
Brand Institute is the global leader in brand name and identity development, providing a broad portfolio of branding and naming related services, including brand strategy, name development, trademark searches, market research, regulatory services, and visual identity solutions.
Drug Safety Institute (DSI) is a wholly owned subsidiary of Brand Institute that provides Brand Institute's healthcare clients with industry-leading guidance pertaining to drug name safety, packaging, and labeling. DSI is comprised of former naming regulatory officials from global government health agencies, including FDA, EMA, Health Canada, AMA, and the WHO.
Contact:
James Dettore
[email protected]
www.brandinstitute.com
SOURCE Brand Institute, Inc.
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