By n.leuba, 24 October, 2022 IPRP Questions and Answers document on Reliance – now published The IPRP is pleased to share a dedicated Questions and Answers document on key aspects for reliance, that was developed by the IPRP Reliance Discussio
By n.luludi, 13 June, 2022 IPRP - 9th Meeting - Public Statement The ninth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 25th and 26th of Ma
By n.leuba, 18 February, 2022 BWG - Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers - now published The Biosimilars Working Group (BWG) has published a Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers. The Primer provi
By n.luludi, 6 December, 2021 IPRP - 8th Meeting - Public Statement The eighth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 19th and 22nd of N
By n.leuba, 13 September, 2021 CTWG/GTWG - International Regulatory Frameworks for Cell and Gene Therapies - now published The IPRP Cell Therapy Working Group (CTWG) and Gene Therapy Working Group (GTWG) have developed the International Regulatory Frameworks for Cell and G
By n.leuba, 23 June, 2021 QWG - Publication of Quality Assessment Report (QAR) – Full Dossier template The IPRP Quality Working Group (QWG) has developed the IPRP Quality Assessment Report (QAR) – Full Dossier template for the assessment of technical in
By n.leuba, 22 June, 2021 IPRP - 7th Meeting - Public Statement The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its seventh meeting on the 7th and 8th of June 2021
By n.leuba, 21 January, 2021 BWG Training Manual The Working Group on Biosimilars (BWG) has published a Training Manual for Regulatory Reviewers on The Basics of the Clinical Comparability Exercise f