Regulatory procedures | Pharmaceuticals

Regulatory Procedures stories

Environmental impact of pharmaceuticals and regulation in the EU
2023-03-07T13:32:00+00:00By Paul Kuiken and Caolan McGuinness
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
The application of patient preference information
2023-01-04T10:39:00+00:00By Kerrie-Anne Ho and Carol Mansfield
Accelerated regulatory pathways: Vaccines for tropical diseases
2023-02-07T11:36:00+00:00By Bruno Speder
The worldwide acceptance of non-legalised eCPPs
2022-10-31T14:41:00+00:00By Tejal Shah and 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
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 and Tanya Rackstraw
The changing role of regulatory operations
2022-08-22T00:01:00+01:00By Vanessa Phillips
Streamlining regulatory processes when implementing new RIMS
2022-08-22T00:01:00+01:00By Helen Donnelly
Data governance as a strategic imperative for regulatory compliance
2022-06-22T14:42:00+01:00By Nancy Pire-Smerkanich
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
Exploring Amgen’s Project Orbis experience with sotorasib (Part 2)
2022-05-26T13:32:00+01:00By Vandana Pathak, Monica Batra, Jacqueline M Kline and Julie Lepin
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 and Julie Lepin
Requirements for the good distribution practice of medicinal products
2021-12-23T14:57:00+00:00By Bettina Von Brockdorff and Lilian M Azzopardi
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 and Rana Ezzeddine