Marketing Authorisation Based on Incomplete Clinical Data: International Experience and Prospects

by D. V. Goryachev, N. E. Uvarova, G. V. Shukshina
Published 2020-09-01

Changing paradigms in bioequivalence trials submitted to the EMA for evaluation – A clinical and regulatory perspective

by Nathaniel Refalo, Daniel Chetcuti, Amy Tanti, Anthony Serracino-Inglott, John Joseph Borg
Published 2017-02-01

Payers’ views of the changes arising through the possible adoption of Adaptive Pathways

by Michael Ermisch, Anna Bucsics, Patricia Vella Bonanno, Francis Arickx, Alexander Bybau, Tomasz Bochenek, Marc Van De Casteele, Eduardo Diogene, Jurij Furst, Kristina Garuoliene, Kristina Garuoliene, Martin van der Graaff, Jolanta Gulbinovic, Jolanta Gulbinovic, Alan Haycox, Jan Jones, Roberta Joppi, Ott Laius, Irene Langner, Anthony Martin, Vanda Markovic-Pekovic, Vanda Markovic-Pekovic, Laura McCullagh, Einar Magnusson, Ellen Nilsen, Gisbert Selke, Catherine Sermet, Steven Simoens, Robert Sauermann, Ad Schuurman, Ricardo Ramos, Vera Vlahovic-Palcevski, Corinne Zara, Brian Godman, Brian Godman
Published 2016-09-01

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

by Hasumati Rahalkar, Hasumati Rahalkar, Alan Sheppard, Gustavo Mendes Lima Santos, Chitralekha Dasgupta, Sonia Mayra Perez-Tapia, Carlos A. Lopez-Morales, Sam Salek, Sam Salek
Published 2021-09-01

Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and...

by Thomas Staab, Georg Isbary, Volker E. Amelung, Jörg Ruof
Published 2016-11-01

Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption

by Claudia Eder, Claudia Wild
Published 2019-01-01

Drug lag and key regulatory barriers in the emerging markets

by Harriet Wileman, Arun Mishra
Published 2010-01-01

New veterinary medicinal products authorised by centralised procedure

by Simona Sturzu
Published 2012-06-01

Current Approaches to Planning and Conducting Clinical Trials of Medicinal Products for the Treatment of Crohn's Disease

by А. N. Bogdanov, E. V. Gorbunova, D. V. Goryachev, E. V. Petraneva
Published 2020-06-01

Has OMP legislation been successful? Yes, though the orphan drug market remains immature

by Oriol Solà-Morales
Published 2019-01-01

Critical evaluation of methods for estimation of increase in systemic drug exposure for renally impaired patients

by Svensson, Robin
Published 2013

Reimbursement Legislations and Decision Making for Orphan Drugs in Central and Eastern European Countries

by Krzysztof Piotr Malinowski, Paweł Kawalec, Wojciech Trąbka, Marcin Czech, Guenka Petrova, Manoela Manova, Manoela Manova, Alexandra Savova, Alexandra Savova, Pero Draganić, Pero Draganić, Lenka Vostalová, Juraj Slabý, Agnes Männik, Kristóf Márky, Zinta Rugaja, Jolanta Gulbinovic, Tomas Tesar, Marian Sorin Paveliu
Published 2019-05-01

Methodological aspects of the development of product files for biomedical cell products

by E. V. Melnikova, O. A. Rachinskaya, O. V. Merkulova, I. S. Semenova, E. O. Kozhevnikova, V. A. Merkulov
Published 2021-07-01

Biomedical Cell Products or High-Tech Drugs?

by V. A. Merkulov, E. V. Melnikova
Published 2019-06-01

Current regulatory and market environment for biosimilars in Serbia

by Pejović Gordana, Filipović Jovan
Published 2014-03-01

2010 and 2011 EU Competition Law and Sector-specific Regulatory Jurisprudence and Case Law Developments with a Nexus to Poland

by Krzysztof Kuik, Anna Mościbroda
Published 2012-11-01