Literature DB >> 25881970

Regulatory watch: Impact of scientific advice from the European Medicines Agency.

Matthias P Hofer1, Christina Jakobsson1, Nikolaos Zafiropoulos1, Spiros Vamvakas1, Thorsten Vetter1, Jan Regnstrom1, Robert J Hemmings2.   

Abstract

Mesh：

Year:  2015        PMID： 25881970     DOI： 10.1038/nrd4621

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  1 in total

1.  Factors influencing non-approval of new drugs in Europe.

Authors:  Michelle Putzeist; Aukje K Mantel-Teeuwisse; Bo Aronsson; Malcolm Rowland; Christine C Gispen-de Wied; Spiros Vamvakas; Arno W Hoes; Hubert G M Leufkens; Hans-Georg Eichler
Journal:  Nat Rev Drug Discov       Date:  2012-12       Impact factor: 84.694
  1 in total
  8 in total

Review 1.  Scientific advice - is drug repurposing missing a trick?

Authors:  Pan Pantziarka
Journal:  Nat Rev Clin Oncol       Date:  2017-05-23       Impact factor: 66.675

2.  The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

Authors:  Giovanni Tafuri; Inês Lucas; Steve Estevão; Jane Moseley; Anne d'Andon; Hannah Bruehl; Elangovan Gajraj; Sonia Garcia; Niklas Hedberg; Marco Massari; Andrea Molina; Mercè Obach; Leeza Osipenko; Frank Petavy; Marco Petschulies; Caridad Pontes; Pierluigi Russo; Anja Schiel; Marc Van de Casteele; Eva-Maria Zebedin-Brandl; Guido Rasi; Spiros Vamvakas
Journal:  Br J Clin Pharmacol       Date:  2018-03-05       Impact factor: 4.335

Review 3.  Development of Exon Skipping Therapies for Duchenne Muscular Dystrophy: A Critical Review and a Perspective on the Outstanding Issues.

Authors:  Annemieke Aartsma-Rus; Volker Straub; Robert Hemmings; Manuel Haas; Gabriele Schlosser-Weber; Violeta Stoyanova-Beninska; Eugenio Mercuri; Francesco Muntoni; Bruno Sepodes; Elizabeth Vroom; Pavel Balabanov
Journal:  Nucleic Acid Ther       Date:  2017-08-10       Impact factor: 5.486

Review 4.  Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.

Authors:  Jane Moseley; Spiros Vamvakas; Michael Berntgen; Alison Cave; Xavier Kurz; Peter Arlett; Virginia Acha; Simon Bennett; Catherine Cohet; Solange Corriol-Rohou; Emma Du Four; Christelle Lamoril; Anja Langeneckert; Maren Koban; Muriel Pasté; Susan Sandler; Karin Van Baelen; Agnese Cangini; Sonia García; Mercè Obach; Emmanuel Gimenez Garcia; Leonor Varela Lema; Hanna-Mari Jauhonen; Piia Rannanheimo; Deborah Morrison; Marc Van De Casteele; Anna Strömgren; Anders Viberg; Amr Makady; Chantal Guilhaume
Journal:  Br J Clin Pharmacol       Date:  2020-04-24       Impact factor: 4.335

Review 5.  Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers.

Authors:  Tingting Qiu; Shuyao Liang; Yitong Wang; Claude Dussart; Borislav Borissov; Mondher Toumi
Journal:  Front Public Health       Date:  2021-11-25

6.  The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study.

Authors:  Aisling Murphy; Nathalie Bere; Spiros Vamvakas; Maria Mavris
Journal:  Front Med (Lausanne)       Date:  2022-01-20

7.  Biomarkers in Medicines Development-From Discovery to Regulatory Qualification and Beyond.

Authors:  Natalie M Hendrikse; Jordi Llinares Garcia; Thorsten Vetter; Anthony J Humphreys; Falk Ehmann
Journal:  Front Med (Lausanne)       Date:  2022-04-26

Review 8.  Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges.

Authors:  Richard Ofori-Asenso; Christine E Hallgreen; Marie Louise De Bruin
Journal:  Front Med (Lausanne)       Date:  2020-10-16
  8 in total

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