Pharmaceuticals | Regulatory Rapporteur

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Pharmaceutical Latest

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
An overview of the regulatory framework for advanced therapies
2023-04-06T07:57:00+01:00By Regulatory Affairs Workgroup SINDUSFARMA
Environmental impact of pharmaceuticals and regulation in the EU
2023-03-07T13:32:00+00:00By Paul Kuiken, Caolan McGuinness
Accelerated regulatory pathways: Vaccines for tropical diseases
2023-02-07T11:36:00+00:00By Bruno Speder
A View of…The Environmental Impact of Pharmaceuticals
2023-02-07T09:26:00+00:00By Paul Kuiken, Caolan McGuinness
Patient information — why do things go wrong?
2023-02-07T09:26:00+00:00By Rory Littlebury
European regulatory fees – complexity, concerns and solutions for efficiency
2023-01-04T10:39:00+00:00By Charlene Senanayake
Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR
2023-01-04T10:39:00+00:00By John Watkins, Morgane Lejeune
An integrated approach to collecting patient experience data: An industry perspective
2023-01-04T10:39:00+00:00By Kerrie-Anne Ho
The worldwide acceptance of non-legalised eCPPs
2022-10-31T14:41:00+00:00By Tejal Shah, Costantino Congiatu
Health Canada: Regulatory Highlights 2021–2022
2022-10-31T14:41:00+00:00By Mary Speagle
Breakthrough therapy designation: From serious diseases to opioid crisis prevention
2022-10-31T14:41:00+00:00By Asoke Mukherjee, John Joines, Charity-Anne Schuller
US FDA CDER and CBER guidance of interest
2022-10-31T14:40:00+00:00By Leah Kleylein
The health economics profile of new pharmaceuticals
2022-09-16T09:26:00+01:00By Chris Wright
Inclusion of older people in drug development and clinical trials: Part 2
2022-09-16T09:25:00+01:00By Kajal Patel
Inclusion of older people in drug development and clinical trials: Part 1
2022-08-22T00:01:00+01:00By Kajal Patel
EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome? Part 2
2022-08-22T00:01:00+01:00By Sarah Landra (née Laird)
How data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals
2022-08-22T00:01:00+01:00By Jacci Squire
Harmonising regulation of medicinal allergen products throughout the European Union – the historic situation and subsequent CMDh guidance
2022-08-22T00:01:00+01:00By Michael Edwards, Tanya Rackstraw
Streamlining regulatory processes when implementing new RIMS
2022-08-22T00:01:00+01:00By Helen Donnelly
Antibiotics in biopharmaceutical production
2022-06-23T09:46:00+01:00By Satish Muchakayala, Jill Makin