Pharmaceuticals | Regulatory Rapporteur

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Pharmaceutical Latest

Controlled substances development – past, present, and future
2023-11-03T00:05:00+00:00By John Joines, Sean Schofield, Radosveta Minkova, Desislava Dimitrova, Joan Boren
Access consortium: in the current submission transmission ecosystem
2023-11-03T00:05:00+00:00By Solange Corriol Rohou, David S. Ross, Amanda Tombs
Transitioning from paper to electronic IFU for EU MDR 2017/745
2023-11-03T00:05:00+00:00By Shikha Malik
Overview of importation strategy from an FDA perspective – PLAIR vs FTZ
2023-11-03T00:05:00+00:00By Manan Shah
A harmonised approach to clinical data standards
2023-11-02T00:05:00+00:00By Leah Kleylein, in conversation with Dave Evans
MHRA seeks to cut approval time by 50% for ‘lowest-risk’ RCTs
2023-10-31T11:38:00+00:00By Alan Booth, Catrin Jackson

Navigating the global supply of starting materials for cell-based therapies
2023-09-01T00:05:00+01:00By Dr Elena Meurer, Dr Jennifer Sales
Warning letters for direct-to-consumer advertising: a five-year retrospective analysis
2023-09-01T00:05:00+01:00By Soundarya Rai, Garima Bansal, Akash Chimegave, Sandeep Maharaj, Manthan D Janodia
Biosimilars CMC development considerations from the sponsor perspective
2023-09-01T00:05:00+01:00By Sateesh Babu, Rajendra Kunda, Korampalli Saidarao, Deepti Jagga, Steve LoCastro, Vivek Tomar, Allison Gillespie
Global life sciences consultancy created from SSI/NDA merger
2023-08-15T16:00:00+01:00By Alan Booth
EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products
2023-08-03T15:00:00+01:00By Simon Hoffman
African Medicines Agency and a new African regulatory ecosystem
2023-08-03T15:00:00+01:00By Ian Hudson, David Mukanga, Chimwenwe Chamdimba, Margareth Ndomonda-Signoda
A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2
2023-08-03T14:59:00+01:00By Hilary Gray
Australia moves to permit therapeutic use of psychedelics
2023-07-03T14:15:00+01:00By Alana Smit
FDA issues guidance for clinical trials of psychedelic drugs
2023-06-27T10:41:00+01:00By Alana Smit
Clinical trials:
Ethical, ecological
and economic change
2023-06-23T14:00:00+01:00By Sarah Roberts
First experiences with the Clinical Trial Regulation – A company perspective
2023-06-23T14:00:00+01:00By Christopher Price, Elmar Schmitt, Martina Hoeth and Georgios Amexis, Global Regulatory Oncology, Merck KGaA; Alexa Hunter, Global Regulatory and Scientific Policy, Merck KGaA; and Lisette Vromans, Zwiers Regulatory Consultancy, The Netherlands
Decentralised clinical trials –
A European Union recommendation paper
2023-06-23T14:00:00+01:00By Pedro Barroso Inacio, Stefani Dilova
A critical review and comparison of the processes when seeking scientific advice in the EU and the USA – Part 1
2023-06-23T14:00:00+01:00By Hilary Gray
Implementation of Regulation (EU) No 536/2014 – A CRO perspective
2023-06-23T14:00:00+01:00By Ana Velimirovic, Britta Dieckhoff, Elisaveta Parapiteva, Iris Romero Matuschek, Polly Halliday, Vicki Iassonidou
Gene therapy gives hope to patients with ‘butterfly skin’
2023-05-25T11:03:00+01:00By Catrin Jackson
Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR
2023-05-18T12:58:00+01:00By Sabine Ruehle, Pierre Omnes, Kathryn Parsley, Gabriel Bohl, Myra Widjojoatmodjo, Janneke Westra-de Vlieger, Jayne Hunt,
supportive members of the TOPRA Biotech and Clinical Trial SPIN groups
G-E-T-ting there – how gene editing technologies could change more than genes
2023-05-18T12:57:00+01:00By Harriet Edwards
Alternatives to animal testing
in the development of ATMPs
2023-05-18T12:56:00+01:00By Michaela Sharpe
Ensuring promotional
materials’ compliance
in the EU
2023-05-18T12:55:00+01:00By Monika Staniulyte, Regulatory Affairs Team Lead, Insuvia. A summary of a webinar originally presented on 15 February, 2023
Regulatory guidelines for
nutraceuticals in India
2023-05-18T12:55:00+01:00By Nikita Kolekar, Kinjal Bera
Registration and post-approval variation of pharmaceutical drugs in Latin America:
challenges and opportunities
2023-04-06T07:57:00+01:00By Akash Jain, Khushboo Vishwakarma, Kajal Gawde