Ian Schofield
@ScripIanSWriting on EU and global regulatory affairs for the Pink Sheet. Views are my own.
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BREAKING: Kamala Harris and Tim Walz have filled their venue in Eau Claire, Wisconsin to the brim today, which is something Donald Trump has repeatedly failed to do. Retweet so all Americans see the energy and enthusiasm surrounding this campaign.
💊 @EP_Environment MEPs adopted their proposals to revamp EU pharmaceutical legislation Directive ⬆️66 ⬇️2 ↔️9 @WeissPernille Regulation ⬆️67 ⬇️6 ↔️7 @woelken #EPlenary vote April I Details in the press release 👇 europarl.europa.eu/news/en/press-…
@WHO members may soon decide to start textual negotiations on #PandemicAccord The new INB draft (scheduled for 16 Oct) should address access to know-how/trade secrets. Here’s why it’s important and what such a measure could look like:
Current drafts of the @WHO Pandemic Accord lack a provision for access to knowhow/trade secrets. So we drafted one. #PandemicAccord @peoplesvaccine medicineslawandpolicy.org/wp-content/upl…
Analysis of the Ukrainian counter-offensive so far Or how to disagree with editors sitting in a newsroom in New York or Washington: 1. "The counteroffensive is going badly compared to expectations". 1.1 We'd better define expectations first, right? Expectations mean what?…
The UK regulator, the MHRA, has approved HIPRA's Bimervax COVID-19 vaccine for marketing in Great Britain. It was approved for use in Northern Ireland four months ago under the EU centralized marketing authorization procedure. gov.uk/government/new…
While the Tories partied, NHS workers were taking iPads to bedsides where children pleaded with their parents to stay alive.
A marketing authorization application for HIPRA's #COVID19 vaccine Bimervax is now under evaluation by the EMA's human drugs committee, the CHMP#. It joins SK Chemicals' Skycovion vaccine, which has been under assessment since August 2022. bit.ly/3lD9hSo
The @EU_Commission's proposals for the overhaul of the EU pharma legislation have been delayed again. They will now be adopted "slightly later" than the tentative date of 29 March because of the "very busy" agenda of the college of commissioners, a spokesman said.
From 2024, the @MHRAgovuk would move to a different model, which will allow "rapid, often near automatic sign-off" for drugs and tech already approved by other trusted regulators eg the US, the EU and Japan. @ScripIanS reports ($) pink.pharmaintelligence.informa.com/PS147898/10m-C…
Novel Anti-Hypertensive Treatment & NSCLC Drug Among New EU Filings bit.ly/3ZLis2d #PinkSheet
The UK is sticking with its decision to increase the rebate that drug companies pay on the sale of branded medicines to the National Health Service under the statutory pricing scheme. Reports @ScripFrancesca ($) pink.pharmaintelligence.informa.com/PS147822/UK-Go…
@ScripIanS reports on the dos and don’ts of using QR barcodes on #Swiss medicine packs and leaflets. Companies must ensure information linked to the code is “useful, medically necessary, clear and not misleading.” #safety @Swissmedic_ pink.pharmaintelligence.informa.com/PS147809/Switz…
Leaked proposals for overhauling the EU #Pharmaceutical legislation reveal plans for a radical restructuring at the @EMA_News that will see the number of its scientific committees reduced from six to two. Read story by @ScripIanS ($) pink.pharmaintelligence.informa.com/PS147816/EU-Pr…
@ScripIanS reports on implications of the “Windsor Framework” on medicines regulation in Northern Ireland. ($) #Brexit #WindsorFramework pink.pharmaintelligence.informa.com/PS147801/UK-EU…
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Who to follow
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Elizabeth Cairns
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Regulatory Affairs Professionals Society
@RAPSorg -
Vibha Sharma
@ScripRegVibha -
Mandy Jackson
@ScripMandy -
Pink Sheet, Citeline Regulatory
@PharmaPinkSheet -
Anju Ghangurde
@scripanjug -
Ian Haydock
@ScripIanHaydock -
Zach Brennan
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In Vivo, Citeline Commercial
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Derrick
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Biopharma Group
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Brian H Yang
@biotech_brian
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