Pharmaceuticals | Regulatory Rapporteur

Pharmaceuticals stories

European regulatory fees – complexity, concerns and solutions for efficiency
2023-01-04T10:39:00+00:00By Charlene Senanayake
An integrated approach to collecting patient experience data: An industry perspective
2023-01-04T10:39:00+00:00By Kerrie-Anne Ho
Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR
2023-01-04T10:39:00+00:00By John Watkins, Morgane Lejeune
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
The worldwide acceptance of non-legalised eCPPs
2022-10-31T14:41:00+00:00By Tejal Shah, Costantino Congiatu
US FDA CDER and CBER guidance of interest
2022-10-31T14:40:00+00:00By Leah Kleylein
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
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
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
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
Part 1: EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome?
2022-06-22T14:53:00+01:00By Sarah Landra (née Laird)
Data governance as a strategic imperative for regulatory compliance
2022-06-22T14:42:00+01:00By Nancy Pire-Smerkanich
Exploring Amgen’s Project Orbis experience with sotorasib (Part 2)
2022-05-26T13:32:00+01:00By Vandana Pathak, Monica Batra, Jacqueline M Kline, Julie Lepin
10 years of pharmacovigilance legislation: the perspective of a national agency
2022-05-20T15:40:00+01:00By Dr Martin Huber, Dr Karl Broich
Amgen’s experience of global expedited regulatory pathways in the development of sotorasib (Part 1)
2022-04-18T13:35:00+01:00By Monica Batra, Vandana Pathak, Jacqueline M Kline, Julie Lepin
CMC considerations for US biosimilars development
2022-04-18T15:18:00+01:00By Merry Christie, Alexandra Beumer Sassi, Valérie Pimpaneau
A regulatory view on the change management process for medicinal products
2022-04-18T14:53:00+01:00By Julien Douillet
Gene therapy products: regulatory expectations and challenges for industry
2022-04-18T13:20:00+01:00By Francesco Lanucara
Requirements for the good distribution practice of medicinal products
2021-12-23T14:57:00+00:00By Bettina Von Brockdorff, Lilian M Azzopardi
Brexit: The regulatory landscape one year on
2022-03-21T09:37:00+00:00By Tracey Roberts, Natalie Coan
Nonclinical immunogenicity evaluation in toxicology studies of biopharmaceuticals
2021-12-23T10:53:00+00:00By Sebastian Joseph
On the path to adoption of decentralised clinical trials
2021-12-23T10:38:00+00:00By Wendi M Lau
Clinical Trial Information System: overview, opportunities and challenges
2021-12-23T09:10:00+00:00By Giulia Detela, Angela Nelson, Rina Kacha, Tijana Pajic, Marko Drobec, Aneta Tsolovska, Tsvetelina Popova
January 2022 Editorial: What does 2022 have in store for clinical trials?
2021-12-23T13:39:00+00:00By Nancy Pire-Smerkanich, Ilse-Maria Nolan
A regulatory lens on an industry imperative: Diversity in clinical research
2021-12-23T11:11:00+00:00By Aman Khera, Sarah Bly
Conditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
2022-01-24T13:25:00+00:00By Bhargavi Pandit, Ian Martin, Rana Ezzeddine
Selection and justification of regulatory starting materials
2022-01-26T13:25:00+00:00By Victoria Goff, John Knight
Brexit − Regulatory and supply chain considerations
2022-02-23T10:19:00+00:00By Graham Donaldson, Regina Dawkins
The EU restriction proposal for intentionally-added microplastics: A focus on solid dosage form medicinal products and food supplements
2022-03-21T10:12:00+00:00By Pilvi Jalonen
Pharmacovigilance regulations post-Brexit
2022-02-23T10:06:00+00:00By Mary Stapleton
Navigating the regulatory landscape for regenerative medicines in Japan
2022-03-21T09:12:00+00:00By Harriet Edwards