E21
Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)
Industry level .................................................................................................. 13
- Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023Page 2/14
1.
- A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP workRevised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023Page 3/14
plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides). - Guideline work led by other working parties
?Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023Page 4/14
The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024. - Guideline work led by other working parties and committees
?Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008). - There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023Page 5/14
new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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?
Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
- Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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?
Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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2.3.
- ?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM). - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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?
In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023Page 10/14
?
Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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4.2.
- ?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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?
To deliver an improved access to raw data (e.g.
- ?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area. - ?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology. - The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023Page 13/14
specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes. - Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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Households' response to the wealth effects of inflation
HYTE in Collaboration With hololive English Unveils the New Limited-Edition Mori Calliope Y40 Bundle
LOS ANGELES, June 29, 2023 /PRNewswire-PRWeb/ -- HYTE, the PC components, peripherals, and lifestyle brand of iBUYPOWER, today, unveiled the new limited-edition Mori Calliope Y40 case and accessory bundle, in collaboration with hololive English, represented by the VTuber agency COVER Corporation.
- HYTE's third case collaboration with hololive English and illustrator Rosuuri, depicts the famous VTuber, Mori Calliope, along with her mascot Death Sensei and scythe, Ricky, on the front and side panels of its Black Y40 PC case.
- Continuing with the design theme of HYTE's previous limited-edition hololive English cases, the back ventilation panel of the Mori Calliope Y40 will feature a chibi illustration of Mori with her catchphrase "GUH."
- The Mori Calliope Y40 Bundle will be available for pre-order in Japan from July 7th to August 15, 2023, and globally, starting in August, from select HYTE retailers.
- To learn more about the Mori Calliope Y40 Bundle, please visit: https://hyte.co/calliope-pr
To learn more about the RDY Mori Calliope system, please visit: https://ibp.gg/mori-rdy-pr
To watch the official Mori Calliope Y40 launch video, please visit: https://youtu.be/5FIqXoa_sL4
ASE Foundation Announces Three E21 Research Grants for Clinician-Scientist and Engineering Partnerships
The aim of the E21 Research Grant program is to promote research partnerships between clinician-scientists and engineering-scientists.
- The aim of the E21 Research Grant program is to promote research partnerships between clinician-scientists and engineering-scientists.
- These awards represent a mechanism to monetarily support daring research collaborations that aim to use engineering solutions to solve a relevant clinical problem in cardiovascular ultrasound.
- The E21 grants are not intended to entirely solve a clinical problem, but to lay the foundation that will lead to major advances in future patient care or clinical practice.
- The ASE Foundation was created to provide support for initiatives, such as training scholarships and scientific research, not supported by membership dues.