Filter
Exclude
Time range
-
Near
グローバルラベルの設定でデバイス割り付けるだけですので、割り付けの管理はしますが、少なくともWork3上ではラベルでプログラムする格好です。 私はiQ-FなのでGOTはデバイスで設定してます。
2
13
望月メゾン👑イラストレーター retweeted
ポートフォリオサイトにて illust5点とWork3点更新しました! ci3d8634.wixsite.com/s-m-a
1
1
82
Replying to @leii10ar
omg hii its SO GOOD, btw im the one telling u to work3 on tiktok with the chained image :33
1
2
130
Claude × Blender でローポリの観葉植物を作りました。 Work3:モンステラ 机に置ける若い小さな株のイメージです🌱 #Blender #3DCG #ClaudeAI #BlenderMCP
2
10
390
Work3
1
11
166
Work3やっと完成! やっとWork3まで終わりましたー🥺朝活ができているようなできていないような。。。😅今朝はたまたまお腹が減りすぎて起きれました☀️ #SHE捗 #シーライクス #webデザイン #Webデザイン入門 #シーママ #Webデザイナー入門 #朝活
4
85
ag1n l3t fudrs fud w3 ar3 h3re for da long t3rm u can ch3k ETH chart w3 work3 and alwais work no matta da pr1ce
2
3
254
無事ネットも回復してwork3完成しました(*´Д`*) 道のりは長い…_φ( ̄ー ̄ ) でもこんなにコツコツ頑張ってるなんて珍しい〜🤩 基礎とかコツコツやるの苦手🫣 がんばっててえらいっ🙌٩( ᐛ )و #SHE捗 #シーライクス
6
71
改めて… #ライターコミュニティ 4月イベントご参加ありがとうございました🖋✨(いっぱい寝た) みなさんの素敵なストーリーに既に涙ちょちょぎれそうなのです……😭 ぜひ、WORK3のラブレターを元にnoteに書いてみるのもおすすめです✨ ▼私が書いた記事▼ note.com/hoshi_st/n/nb7a9ca4… #シーライクス
17
246
ทำมาเป็นอวดbath &body work3ขวด อีห่า กุเข้าชอปวันนั้นลดเหลือ300ทุกขวด สภาพผ้าปูอุบาทจัดจนต้องถ่ายบนเสื้อตัวเอง กุจะบ้า5555555555 กุอวดให้บ้าง กะอีแค่ครีมอาบน้ำ😀 มึงเห่อหมอยเหลือเกิน กุอวดคืนบ้าง ตลกดีได้อวดอะไรแปลกๆ
1
1
2
318
Replying to @InOneProjects
The platform is setup in a slightly rigid way. Think of it like this you have a cascading claude.md/agents.md Top level home claude.md which also contains skills. Then I Have a Github folder Then type of project (Website, Game, Writing, Tool) Then framework (Monogame, ThreeJS, Ruby on Rails etc) Then the actual project (Name of it in a folder) Then below that Master/work1,work2,work3 etc. That allows you to have claude.md/agent.mds all the way down at each folder level, which is very key. I then connect my github, set them up in projects as the active/ship next...and then u can click it on the left to get one loading into the workspace. I have in my claude.md instructions that help with the workflow. There is also the commander which has awareness of your workspace and worktrees, and can help you startup stuff too. Totally understand it can be a bit annoying to transition, but once you get going, it's VERY good :)
1
2
40
pgsd $nwbo @alphavestcap Re: None Friday, April 10, 2026 1:23:51 AM Post# of 820964 Interesting notes on the new MHRA-NICE aligned pathway which includes a deferral element for companies where earlier submission to NICE is not possible. New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service: New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service 9 April 2026 - Medicines Licensing, MHRA (UK) Last updated: 9 April 2026 Update: MHRA and NICE are launching an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines and provide a more efficient route for industry. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible. 1. How will the MHRA-NICE aligned pathway benefit patients in England? It will benefit patients in England who are set to receive some new medicines three to six months earlier under the streamlined approval process being launched.1 When will the MHRA-NICE aligned pathway be launched? The aligned pathway will be launched on 1 April 2026.1 What is the main driver for the MHRA-NICE aligned ? It will help to bring NICE’s decision-making process forward to run alongside MHRA’s, resulting in decisions on licensing and value being made at the same time.1 How can pharmaceutical companies benefit from using the MHRA-NICE aligned pathway?5 Earlier NHS market access – NICE TA guidance will be published at the same time as MHRA marketing authorisation. Predictable timelines – priority scheduling from NICE and coordinated milestones to support forward-planning. Commercial benefits realised sooner due to earlier entry into the NHS and longer exclusivity before Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) rebates apply. NHS and global markets will be notified earlier. While the aligned pathway is one part of a broader ecosystem, the ambition is that over time, it will contribute to speeding up NHS adoption of new medicines. Which therapeutic areas or topics is the MHRA-NICE aligned pathway suitable for?5 All therapeutic areas are eligible for the aligned pathway and there is no cap on the number of companies who can use it. Topics coming through the following pathways will be prioritised for scheduling to the MHRA-NICE aligned pathway: Innovative Licensing and Access Pathway (ILAP), National licensing route, ACCESS consortium or Project Orbis While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend it in, at minimum, the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. What advice is available for the MHRA-NICE aligned pathway? The Integrated Scientific Advice service provides pharmaceutical companies with coordinated scientific advice on evidence requirements for market authorisation and health technology assessment, through a single, streamlined process. The service is most suitable for products in clinical development and aiming to follow MHRA and NICE aligned pathway timelines. You can ask for advice on: the design of pivotal studies (including those already in progress, although the MHRA recommend requesting as early as possible), generation of real-world evidence and strategic planning for regulatory and HTA requirements. The Integrated Scientific Advice service does not provide joint scientific advice for medical devices. However, NICE offers separate services for medical technology developers and there are separate services for medicine developers wanting only regulatory advice from the MHRA or only HTA advice from NICE. Is there guidance available on how to get Integrated Scientific Advice from the MHRA and NICE? Yes there is, in the Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE. Is it possible to get more help to apply for medicines Integrated Scientific Advice? Yes it is, in the Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA). This is extra information for the MHRA and NICE Integrated Scientific Advice service. Is integrated scientific advice mandatory a mandatory requirement for the MHRA-NICE aligned pathway?5 While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend at a minimum, for the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. Is the MHRA-NICE aligned pathway mandatory or optional? The aligned pathway is entirely optional, giving companies full control over their submission strategy.3 Companies can choose to request a later submission date, following the traditional sequential approach.3 This flexibility is particularly valuable for companies whose global development programmes or regulatory timelines do not currently align with the earlier submission requirements.3 Both, the MHRA and NICE continue to operate independently and maintain their own distinct evaluation standards. How the MHRA-NICE aligned pathway will work3 Currently, there’s a 90-day gap between MHRA marketing authorisation grant and NICE guidance publication. Under the aligned pathway, NICE’s scheduling processes is being brought forward to eliminate this delay. NICE appraisal committee meetings will now be able to take place in public before marketing authorisation grant. NICE can also publish both draft guidance and final draft guidance before the MHRA decision – with the caveat that recommendations are subject to marketing approval. This represents a significant shift in how NICE currently coordinates its activities. What’s can pharmaceutical companies prepare for the MHRA-NICE aligned pathway?3 To facilitate these changes, the aligned pathway requires companies to engage with NICE early by registering their product on UK PharmaScan at least 3 years prior to expected MHRA marketing authorisation. Companies will also need to commit (at global level) to adhering to the timelines. To support this approach, NICE will offer priority scheduling, ensuring that these medicines can progress through its evaluation process in time to achieve simultaneous publication with regulatory decisions. NICE is also offering an improved and fully integrated scientific advice service, designed to help companies adhere to the timings by gaining clarity on evidence requirements and avoiding unnecessary delays. What will happen in those instances when an earlier submission to NICE is not possible?3 NICE recognises that not all medicines will be suitable for the aligned pathway. Some complex topics may require alternate scheduling, where NICE will not progress to committee until marketing authorisation is granted. This ensures that NICE maintains its rigorous evaluation standards while providing flexibility for more challenging assessments. For companies that cannot meet NICE submission timelines which puts the start of their NICE evaluation before marketing authorisation, NICE will publish a deferral.3 This will provide complete transparency on when NICE will evaluate a medicine following grant of marketing authorisation. Will the MHRA and NICE maintain independence and transparency?3 NICE and MHRA will continue to operate independently, maintaining their distinct evaluation standards. While NICE is aligning its timelines and improving operational information sharing, each organisation will retain its own rigorous assessment criteria and decision-making processes. MHRA will continue to focus on safety, quality and efficacy for regulatory approval, while NICE will maintain its established framework for evaluating clinical and cost effectiveness. NICE also remains committed to maintaining its public committee meetings and transparency standards. What is the sequence of steps that should be followed for the MHRA-NICE aligned pathway?5 Step 1: Register on UK PharmaScan Register your medicine on UK PharmaScan, the national horizon scanning database, at least 3 years before your expected MHRA marketing authorisation. This is an essential requirement for joining the MHRA-NICE aligned pathway. Step 2: Confirm your commitment At the NICE topic selection stage, confirm to NICE that you can submit to their optimal timelines. The NICE team will then share coordinated timelines linked to your expected marketing authorisation. There is no separate application process. Step 3: Submit to NICE and MHRA Submit your dossiers to the MHRA and NICE. Each organisation will assess the evidence and reach its own decisions independently. For optimal timelines, submit to NICE around 7 months before your expected MHRA marketing authorisation. Depending on the MHRA route, this may mean submitting to NICE before the MHRA. Step 4: Receive aligned decisions For products on track with the pathway, NICE will schedule its appraisal committee meetings, draft guidance and final draft guidance to take place before your MHRA marketing authorisation is granted. Any draft guidance published before marketing authorisation will make clear that final recommendations are subject to the licence being granted. NICE will then publish its technology appraisal to coincide with your MHRA marketing authorisation. Further Reading MHRA-NICE pathway opens for business – everything you need to know to get started, 1 April 20266, nice.org.uk References 1. Press release: Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process, 17 March 2026, MHRA. 2. Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA), 20 February 2026, MHRA 3. Same time decisions on licensing and value – what pharmaceutical companies need to know, 10 October 2025, NICE 4. Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE, 24 March 2026, MHRA 5. Guidance: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway, 1 April 2026, MHRA pharmavibes.co.uk/2026/04/09… x.com/peter_brit/status/2042…
#dcvax $nwbo #gbm Interesting notes on the new MHRA-NICE aligned pathway which includes a deferral element for companies where earlier submission to NICE is not possible. New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service: New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service 9 April 2026 - Medicines Licensing, MHRA (UK) Last updated: 9 April 2026 Update: MHRA and NICE are launching an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines and provide a more efficient route for industry. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.1 How will the MHRA-NICE aligned pathway benefit patients in England? It will benefit patients in England who are set to receive some new medicines three to six months earlier under the streamlined approval process being launched.1 When will the MHRA-NICE aligned pathway be launched? The aligned pathway will be launched on 1 April 2026.1 What is the main driver for the MHRA-NICE aligned ? It will help to bring NICE’s decision-making process forward to run alongside MHRA’s, resulting in decisions on licensing and value being made at the same time.1 How can pharmaceutical companies benefit from using the MHRA-NICE aligned pathway?5 Earlier NHS market access – NICE TA guidance will be published at the same time as MHRA marketing authorisation. Predictable timelines – priority scheduling from NICE and coordinated milestones to support forward-planning. Commercial benefits realised sooner due to earlier entry into the NHS and longer exclusivity before Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) rebates apply. NHS and global markets will be notified earlier. While the aligned pathway is one part of a broader ecosystem, the ambition is that over time, it will contribute to speeding up NHS adoption of new medicines. Which therapeutic areas or topics is the MHRA-NICE aligned pathway suitable for?5 All therapeutic areas are eligible for the aligned pathway and there is no cap on the number of companies who can use it. Topics coming through the following pathways will be prioritised for scheduling to the MHRA-NICE aligned pathway: Innovative Licensing and Access Pathway (ILAP), National licensing route, ACCESS consortium or Project Orbis While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend it in, at minimum, the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. What advice is available for the MHRA-NICE aligned pathway? The Integrated Scientific Advice service provides pharmaceutical companies with coordinated scientific advice on evidence requirements for market authorisation and health technology assessment, through a single, streamlined process. The service is most suitable for products in clinical development and aiming to follow MHRA and NICE aligned pathway timelines. You can ask for advice on: the design of pivotal studies (including those already in progress, although the MHRA recommend requesting as early as possible), generation of real-world evidence and strategic planning for regulatory and HTA requirements. The Integrated Scientific Advice service does not provide joint scientific advice for medical devices. However, NICE offers separate services for medical technology developers and there are separate services for medicine developers wanting only regulatory advice from the MHRA or only HTA advice from NICE. Is there guidance available on how to get Integrated Scientific Advice from the MHRA and NICE? Yes there is, in the Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE. Is it possible to get more help to apply for medicines Integrated Scientific Advice? Yes it is, in the Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA). This is extra information for the MHRA and NICE Integrated Scientific Advice service. Is integrated scientific advice mandatory a mandatory requirement for the MHRA-NICE aligned pathway?5 While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend at a minimum, for the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. Is the MHRA-NICE aligned pathway mandatory or optional? The aligned pathway is entirely optional, giving companies full control over their submission strategy.3 Companies can choose to request a later submission date, following the traditional sequential approach.3 This flexibility is particularly valuable for companies whose global development programmes or regulatory timelines do not currently align with the earlier submission requirements.3 Both, the MHRA and NICE continue to operate independently and maintain their own distinct evaluation standards. How the MHRA-NICE aligned pathway will work3 Currently, there’s a 90-day gap between MHRA marketing authorisation grant and NICE guidance publication. Under the aligned pathway, NICE’s scheduling processes is being brought forward to eliminate this delay. NICE appraisal committee meetings will now be able to take place in public before marketing authorisation grant. NICE can also publish both draft guidance and final draft guidance before the MHRA decision – with the caveat that recommendations are subject to marketing approval. This represents a significant shift in how NICE currently coordinates its activities. What’s can pharmaceutical companies prepare for the MHRA-NICE aligned pathway?3 To facilitate these changes, the aligned pathway requires companies to engage with NICE early by registering their product on UK PharmaScan at least 3 years prior to expected MHRA marketing authorisation. Companies will also need to commit (at global level) to adhering to the timelines. To support this approach, NICE will offer priority scheduling, ensuring that these medicines can progress through its evaluation process in time to achieve simultaneous publication with regulatory decisions. NICE is also offering an improved and fully integrated scientific advice service, designed to help companies adhere to the timings by gaining clarity on evidence requirements and avoiding unnecessary delays. What will happen in those instances when an earlier submission to NICE is not possible?3 NICE recognises that not all medicines will be suitable for the aligned pathway. Some complex topics may require alternate scheduling, where NICE will not progress to committee until marketing authorisation is granted. This ensures that NICE maintains its rigorous evaluation standards while providing flexibility for more challenging assessments. For companies that cannot meet NICE submission timelines which puts the start of their NICE evaluation before marketing authorisation, NICE will publish a deferral.3 This will provide complete transparency on when NICE will evaluate a medicine following grant of marketing authorisation. Will the MHRA and NICE maintain independence and transparency?3 NICE and MHRA will continue to operate independently, maintaining their distinct evaluation standards. While NICE is aligning its timelines and improving operational information sharing, each organisation will retain its own rigorous assessment criteria and decision-making processes. MHRA will continue to focus on safety, quality and efficacy for regulatory approval, while NICE will maintain its established framework for evaluating clinical and cost effectiveness. NICE also remains committed to maintaining its public committee meetings and transparency standards. What is the sequence of steps that should be followed for the MHRA-NICE aligned pathway?5 Step 1: Register on UK PharmaScan Register your medicine on UK PharmaScan, the national horizon scanning database, at least 3 years before your expected MHRA marketing authorisation. This is an essential requirement for joining the MHRA-NICE aligned pathway. Step 2: Confirm your commitment At the NICE topic selection stage, confirm to NICE that you can submit to their optimal timelines. The NICE team will then share coordinated timelines linked to your expected marketing authorisation. There is no separate application process. Step 3: Submit to NICE and MHRA Submit your dossiers to the MHRA and NICE. Each organisation will assess the evidence and reach its own decisions independently. For optimal timelines, submit to NICE around 7 months before your expected MHRA marketing authorisation. Depending on the MHRA route, this may mean submitting to NICE before the MHRA. Step 4: Receive aligned decisions For products on track with the pathway, NICE will schedule its appraisal committee meetings, draft guidance and final draft guidance to take place before your MHRA marketing authorisation is granted. Any draft guidance published before marketing authorisation will make clear that final recommendations are subject to the licence being granted. NICE will then publish its technology appraisal to coincide with your MHRA marketing authorisation. Further Reading MHRA-NICE pathway opens for business – everything you need to know to get started, 1 April 20266, nice.org.uk References 1. Press release: Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process, 17 March 2026, MHRA. 2. Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA), 20 February 2026, MHRA 3. Same time decisions on licensing and value – what pharmaceutical companies need to know, 10 October 2025, NICE 4. Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE, 24 March 2026, MHRA 5. Guidance: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway, 1 April 2026, MHRA pharmavibes.co.uk/2026/04/09…
5
586
#dcvax $nwbo #gbm Interesting notes on the new MHRA-NICE aligned pathway which includes a deferral element for companies where earlier submission to NICE is not possible. New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service: New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service 9 April 2026 - Medicines Licensing, MHRA (UK) Last updated: 9 April 2026 Update: MHRA and NICE are launching an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines and provide a more efficient route for industry. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.1 How will the MHRA-NICE aligned pathway benefit patients in England? It will benefit patients in England who are set to receive some new medicines three to six months earlier under the streamlined approval process being launched.1 When will the MHRA-NICE aligned pathway be launched? The aligned pathway will be launched on 1 April 2026.1 What is the main driver for the MHRA-NICE aligned ? It will help to bring NICE’s decision-making process forward to run alongside MHRA’s, resulting in decisions on licensing and value being made at the same time.1 How can pharmaceutical companies benefit from using the MHRA-NICE aligned pathway?5 Earlier NHS market access – NICE TA guidance will be published at the same time as MHRA marketing authorisation. Predictable timelines – priority scheduling from NICE and coordinated milestones to support forward-planning. Commercial benefits realised sooner due to earlier entry into the NHS and longer exclusivity before Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) rebates apply. NHS and global markets will be notified earlier. While the aligned pathway is one part of a broader ecosystem, the ambition is that over time, it will contribute to speeding up NHS adoption of new medicines. Which therapeutic areas or topics is the MHRA-NICE aligned pathway suitable for?5 All therapeutic areas are eligible for the aligned pathway and there is no cap on the number of companies who can use it. Topics coming through the following pathways will be prioritised for scheduling to the MHRA-NICE aligned pathway: Innovative Licensing and Access Pathway (ILAP), National licensing route, ACCESS consortium or Project Orbis While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend it in, at minimum, the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. What advice is available for the MHRA-NICE aligned pathway? The Integrated Scientific Advice service provides pharmaceutical companies with coordinated scientific advice on evidence requirements for market authorisation and health technology assessment, through a single, streamlined process. The service is most suitable for products in clinical development and aiming to follow MHRA and NICE aligned pathway timelines. You can ask for advice on: the design of pivotal studies (including those already in progress, although the MHRA recommend requesting as early as possible), generation of real-world evidence and strategic planning for regulatory and HTA requirements. The Integrated Scientific Advice service does not provide joint scientific advice for medical devices. However, NICE offers separate services for medical technology developers and there are separate services for medicine developers wanting only regulatory advice from the MHRA or only HTA advice from NICE. Is there guidance available on how to get Integrated Scientific Advice from the MHRA and NICE? Yes there is, in the Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE. Is it possible to get more help to apply for medicines Integrated Scientific Advice? Yes it is, in the Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA). This is extra information for the MHRA and NICE Integrated Scientific Advice service. Is integrated scientific advice mandatory a mandatory requirement for the MHRA-NICE aligned pathway?5 While integrated scientific advice is not a requirement of the aligned pathway, MHRA and NICE strongly recommend at a minimum, for the design of your pivotal clinical trials. Early scientific advice can help you design your clinical development programme to meet both regulatory and health technology appraisal requirements, helping you to adhere to aligned pathway timelines. Is the MHRA-NICE aligned pathway mandatory or optional? The aligned pathway is entirely optional, giving companies full control over their submission strategy.3 Companies can choose to request a later submission date, following the traditional sequential approach.3 This flexibility is particularly valuable for companies whose global development programmes or regulatory timelines do not currently align with the earlier submission requirements.3 Both, the MHRA and NICE continue to operate independently and maintain their own distinct evaluation standards. How the MHRA-NICE aligned pathway will work3 Currently, there’s a 90-day gap between MHRA marketing authorisation grant and NICE guidance publication. Under the aligned pathway, NICE’s scheduling processes is being brought forward to eliminate this delay. NICE appraisal committee meetings will now be able to take place in public before marketing authorisation grant. NICE can also publish both draft guidance and final draft guidance before the MHRA decision – with the caveat that recommendations are subject to marketing approval. This represents a significant shift in how NICE currently coordinates its activities. What’s can pharmaceutical companies prepare for the MHRA-NICE aligned pathway?3 To facilitate these changes, the aligned pathway requires companies to engage with NICE early by registering their product on UK PharmaScan at least 3 years prior to expected MHRA marketing authorisation. Companies will also need to commit (at global level) to adhering to the timelines. To support this approach, NICE will offer priority scheduling, ensuring that these medicines can progress through its evaluation process in time to achieve simultaneous publication with regulatory decisions. NICE is also offering an improved and fully integrated scientific advice service, designed to help companies adhere to the timings by gaining clarity on evidence requirements and avoiding unnecessary delays. What will happen in those instances when an earlier submission to NICE is not possible?3 NICE recognises that not all medicines will be suitable for the aligned pathway. Some complex topics may require alternate scheduling, where NICE will not progress to committee until marketing authorisation is granted. This ensures that NICE maintains its rigorous evaluation standards while providing flexibility for more challenging assessments. For companies that cannot meet NICE submission timelines which puts the start of their NICE evaluation before marketing authorisation, NICE will publish a deferral.3 This will provide complete transparency on when NICE will evaluate a medicine following grant of marketing authorisation. Will the MHRA and NICE maintain independence and transparency?3 NICE and MHRA will continue to operate independently, maintaining their distinct evaluation standards. While NICE is aligning its timelines and improving operational information sharing, each organisation will retain its own rigorous assessment criteria and decision-making processes. MHRA will continue to focus on safety, quality and efficacy for regulatory approval, while NICE will maintain its established framework for evaluating clinical and cost effectiveness. NICE also remains committed to maintaining its public committee meetings and transparency standards. What is the sequence of steps that should be followed for the MHRA-NICE aligned pathway?5 Step 1: Register on UK PharmaScan Register your medicine on UK PharmaScan, the national horizon scanning database, at least 3 years before your expected MHRA marketing authorisation. This is an essential requirement for joining the MHRA-NICE aligned pathway. Step 2: Confirm your commitment At the NICE topic selection stage, confirm to NICE that you can submit to their optimal timelines. The NICE team will then share coordinated timelines linked to your expected marketing authorisation. There is no separate application process. Step 3: Submit to NICE and MHRA Submit your dossiers to the MHRA and NICE. Each organisation will assess the evidence and reach its own decisions independently. For optimal timelines, submit to NICE around 7 months before your expected MHRA marketing authorisation. Depending on the MHRA route, this may mean submitting to NICE before the MHRA. Step 4: Receive aligned decisions For products on track with the pathway, NICE will schedule its appraisal committee meetings, draft guidance and final draft guidance to take place before your MHRA marketing authorisation is granted. Any draft guidance published before marketing authorisation will make clear that final recommendations are subject to the licence being granted. NICE will then publish its technology appraisal to coincide with your MHRA marketing authorisation. Further Reading MHRA-NICE pathway opens for business – everything you need to know to get started, 1 April 20266, nice.org.uk References 1. Press release: Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process, 17 March 2026, MHRA. 2. Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA), 20 February 2026, MHRA 3. Same time decisions on licensing and value – what pharmaceutical companies need to know, 10 October 2025, NICE 4. Guidance: Medicines: Get integrated scientific advice from the MHRA and NICE, 24 March 2026, MHRA 5. Guidance: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway, 1 April 2026, MHRA pharmavibes.co.uk/2026/04/09…
2
25
919
参照するコードネームに、WORK3とWORKみたいなてきとーなものを付けてはいけない(今日の戒め
1
2
55
Photoshop操作編、work3まで終わった🙌 今回のworkは解説動画見ずに完成することができた! ただ、選択範囲の微調整の方法が解説動画と少し違っていたのでメモしつつ学びの整理📝 スローペースだけど引き続き頑張ろう🐢
1
3
39
私・いるるは、潜在意識を信じきれない時期があったんです。 「思うだけで叶う」って言葉、 どこかで「でも現実はさ……」って思ってました。 彼から連絡がこない日。 SNSで他の女性の影がちらついた日。 そういう日って、頭でわかってても ぐるぐる思考が止まらないじゃないですか。 そのぐるぐる思考はノートに書きまくりたい!って思ってたんですよね。 そこで誕生したのが、『潜在意識で叶える! 片想い成就100日ワークブック』❤ ★Work1「思い」 「とっくに叶っている私」というゴールを確定させる。 うまくいったあとの彼と私を、思いっきり書く30日間。 ★Work2「エゴ」 「叶わない理由」を一蹴する。 不安・焦り・怒り、全部書き出して受け流すコツを掴む30日間。 ★Work3「自愛」 「何があっても大丈夫な私」へ。 自分を一番の味方にして、恋愛成就の土台を固める40日間。 毎日1ページ、計100日。 6年間ほめ♡レンをやってきて「書くことで意識が変わった人」をたくさん見てきました。次は、あなたの番です!! Amazon総合108位(3月23日8時時点)。 📚 潜在意識で叶える!片想い成就100日Workbook → amazon.co.jp/dp/4911115122
20
1,099
Amazon総合142位になったほめ♡レンのワークブック『潜在意識で叶える!100日ワークブック』🎊恋愛心理で1位、Amazon総合で142位でびっくりしています!(3月22日9時時点) 「片想いは卒業して、彼と幸せになりたい」 その願い、このワークで「朝飯前」に叶えましょう! このワークは、「思い」「エゴ」「自愛」の3部構成となっています。 ★Work1:思い→「とっくに叶っている私」というゴールを確定させる♡ まずは「思い」をノートで体感。潜在意識の恋愛成就の基本を掴みます。(30日) ★ Work2:エゴ→「叶わない理由」を一蹴する♡ 不安や焦り、怒りなどのエゴを書き出し、受け流すコツを習得。(30日) ★Work3:自愛→「何があっても大丈夫な私」へ 自分を一番の味方にする! 恋愛成就の土台を固めます。(40日) ほめ♡レンの超人気コンテンツ「恋愛成就報告体験談」のYouTubeは110本以上!! 次はあなたの番🎉 📚 潜在意識で叶える!片想い成就100日Workbook ▶ amazon.co.jp/dp/4911115122
13
1,702
ほめ♡レン初のワークブック 『潜在意識で叶える! 片思い成就100日Workbook』がAmazonで恋愛心理1位どころか、Amazon全書籍で142位 ‼️‼️ 今朝5度見したw ありがたき幸せすぎる♥️♥️ ★100日ワークの構成★ Work1:思い→「とっくに叶っている私」というゴールを確定させる♡ まずは「思い」をノートで体感。潜在意識の恋愛成就の基本を掴みます。 ★ Work2:エゴ→「叶わない理由」を一蹴する♡ 不安や焦り、怒りなどのエゴを書き出し、受け流すコツを習得。 ★Work3:自愛→「何があっても大丈夫な私」へ 自分を一番の味方にする! 恋愛成就の土台を固めます。 ほめ♡レンの超人気コンテンツ「恋愛成就報告体験談」のYouTubeは、すでに110本以上!! 次はあなたの番‼️ 「片想いは卒業して、彼と幸せになりたい」 その願い、このワークで「朝飯前」に叶えていきましょう! ずーっとほめ♡レンを応援してくれたみなさまも、本当にありがとう‼️ URLは、コメント欄に♥️
3
3
19
1,924
本日、ついに❤ 発売!!!!! 『潜在意識で叶える! 片思い成就100日Workbook』 わーーーーーーーーーいぱちぱち。 そう思うから、そうなるーー。 YouTube 登録者 14万人 Voicy 年間ランキング 1位(2025年 占い・運命編) を誇る「ほめ♡レン」から、片想い成就を叶える初の書き込み式ワークブックが登場! このワークブックは、累計 850本以上の動画、1000本以上の音声配信を通して、数え切れないほどの恋愛成就を見届けた私たちが贈る 100日間のプログラム。 毎日1つの課題があるから、ノートにペンを走らせるだけで、「目の前で何が起きていても関係ない。自分を信じよう」という感覚が掴めるようになり、自然と「彼とラブラブな私」という「思い」に居座れるようになります♡ 潜在意識の願望成就は、驚くほどシンプルです。 「彼とラブラブな私」という最終的なゴール(思い)を今、決めること。 たったそれだけで、現実はその通りに動き出します。 「彼がそっけないから、叶うわけない」 「LINEが来ないから、愛されていない」 こんな悩みやモヤモヤさえも、この 100日間のワークブックの書き込みを通して、意識が整理され、本当に望む現実が動き出します。 ★100日ワークの構成★ Work1:思い→「とっくに叶っている私」というゴールを確定させる♡ まずは「思い」をノートで体感。潜在意識の恋愛成就の基本を掴みます。 Work2:エゴ→「叶わない理由」を一蹴する♡ 不安や焦り、怒りなどのエゴを書き出し、受け流すコツを習得。 Work3:自愛→「何があっても大丈夫な私」へ 自分を一番の味方にする! 恋愛成就の土台を固めます。 ★次はあなたの番です★ ほめ♡レンの超人気コンテンツ「恋愛成就報告体験談」のYouTubeは、すでに110本以上!! たくさんの成就報告が証明する圧倒的なパワーを、次はあなたのその手で、このワークを通して体感してください。 「片想いは卒業して、彼と幸せになりたい」 その願い、このワークで「朝飯前」に叶えていきましょう! x.gd/RRpB7 著者プロフィール:ほめ♡レン 編集者・めぐると音楽家・いるるが、潜在意識の願望成就「そう思うから、そうなる」を発信。2万件近くの相談実績、110本を超える実例公開など、真摯に寄り添う姿勢と圧倒的な再現性が、片想いや復縁に悩む人から絶大な支持を得ている。
2
35
2,997