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Regulatory Affairs Newsletter

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MHRA Update (WC 30 Sept)

Clinical investigations guidance Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated section on ‘Amendments’ to reflect changes to the process. Time updated: 9:34am, 26 September 2024 Access Consortium: joint pipeline meetings Page summary: The Access Consortium is offering joint pipeline meetings to pharmaceutical and…
Ben Kemp
October 2, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Update (WC 30 Sept)

Persistent organic pollutants (POPs) Page summary: Information relating to persistent organic pollutants (POPs). Change made: Added link to a guide on ‘When electrical and electronic equipment (EEE) becomes waste (WEEE)’. Time updated: 10:55am, 25 September 2024 Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved…
Ben Kemp
October 2, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 30 Sept)

Data protection fee regime: proposed changes Page summary: We’re seeking views on proposals to amend to amend the current data protection fees payable by data controllers to the Information Commissioner’s Office (ICO). Change made: Deadline to respond to this consultation is extended until 11:55pm on 3 October 2024. Time updated: 10:00am, 23 September 2024 Mexico: UK Science and Innovation Network…
Ben Kemp
October 2, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 30 Sept)

Data protection fee regime: proposed changes Page summary: We’re seeking views on proposals to amend to amend the current data protection fees payable by data controllers to the Information Commissioner’s Office (ICO). Change made: Deadline to respond to this consultation is extended until 11:55pm on 3 October 2024. Time updated: 10:00am, 23 September 2024 Access resources to develop and exploit…
Ben Kemp
October 2, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

UK and Ireland Association of Forensic Toxicologists Conference, 10-11th October 2024

I would like to draw your attention to the upcoming UK and Ireland Association of Forensic Toxicologists (UKIAFT) meeting on 10-11th October at Voco Hotel, Leicester (agenda attached). UKIAFT has an annual meeting focussing on post-mortem / forensic toxicology (http://www.ukiaft.co.uk/). Registration includes a tour of the Leicester Tigers stadium (adjacent to Voco) with drinks and canapes followed by the conference meal with…
Ben Kemp
October 1, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

SKUL Slovakia – Update on IVDR transition

Due to the enormous increase in the number of submitted applications and the extension of processing times, the ZP Section recommends: Not to submit a notice of ZP, which is not subject to the notification obligation pursuant to Act 362/2011, §110 b, par. 2, i.e. not to submit a notification on the availability of Class I medical devices and Class…
Ben Kemp
October 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

“Understanding IVDR Clinical Evidence Requirements”

Join this free webinar to get invaluable insights on how to understand the Clinical Evidence IVDR life cycle concept to ensure continuous safety and performance of state-of-the-art IVDs. Sebastian Grömminger Principal Consultant at Entourage and I will explore how to master the Clinical Evidence IVDR life cycle concept to ensure continuous supply of safe and state of the art IVDs.…
Ben Kemp
October 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Registration now open for webinar on Implementing the new UK Clinical Trials regulations

The Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Health Research Authority (HRA), is hosting a short webinar to introduce our joint plans to share draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. If you sponsor clinical trials or are an interested stakeholders from academia or…
Ben Kemp
October 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

IP Connect newsletter – September 2024

International UK reinforces commitment to global IP collaboration in talks with Singapore The IPO lead global dialogue on IP in August, during the 13th annual IP Week in Singapore event. The IPO hosted a high-profile event at Eden Hall titled 'From Intellectual Assets to Capital: The Branding and Innovation Edge'. The discussion, featuring the IPO's Interim Chief Analyst, Rich Corken,…
Ben Kemp
October 1, 2024
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