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Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

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星期三, 二月 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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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/58124/2023
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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/58124/2023
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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)
EMA/CHMP/58124/2023
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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)
EMA/CHMP/58124/2023
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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)
EMA/CHMP/58124/2023
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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)
EMA/CHMP/58124/2023
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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/58124/2023
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?

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)
EMA/CHMP/58124/2023
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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)
EMA/CHMP/58124/2023
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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/58124/2023

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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)
EMA/CHMP/58124/2023
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LALA U.S. Wins High Honors at 2022 World Dairy Expo

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星期二, 九月 20, 2022

Nine new and traditional dairy products from LALA U.S. were honored as among the best in North America during the 2022 World Dairy Expo (WDE) Championship Dairy Product Contest.

Key Points:

Nine new and traditional dairy products from LALA U.S. were honored as among the best in North America during the 2022 World Dairy Expo (WDE) Championship Dairy Product Contest.
LALA Strawberry Lowfat Blended Yogurt and LALA Postres Autnticos Fresas con Crema Dessert Yogurt Smoothie each won first place in their respective category.
LALA added the new dessert yogurt earlier this year to its highly respected line of yogurt products.
On October 4, the contests auction will be held at World Dairy Expo in Madison, where all category 1st place winners will be auctioned.

LALA® Introduces New Breakfast ‘Licuados’

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星期二, 七月 5, 2022

Supermarket, Retail, Specialty, Food, Beverage, Honey, Dairy product, Licuado, Dairy, Milk, Fruit, Breakfast, Cheese, Grupo Lala, Yogurt, Marketing, Vitamin, LALA, Multimedia, Grocery store, Perfume

LALA U.S. is introducing authentic licuados traditional Mexican breakfast smoothies containing milk, fruit, and oats to dairy cases in Walmart and Hispanic-specialty grocers this month.

Key Points:

LALA U.S. is introducing authentic licuados traditional Mexican breakfast smoothies containing milk, fruit, and oats to dairy cases in Walmart and Hispanic-specialty grocers this month.
View the full release here: https://www.businesswire.com/news/home/20220705005709/en/
LALA Introduces New Breakfast Licuados in Papaya, Mango-Carrot and Vanilla Honey.
(Photo: Business Wire)
LALA Licuados are the perfect way to start your morning, said Matt Okeson, Head of Marketing and R&D for LALA U.S. With the goodness of oats, real milk, and a blend of real fruits, LALA Licuados are a Hispanic breakfast standard in a convenient ready-to-drink format.
Our focus is to create a traditional breakfast offering with LALA Licuados, said Mr. Okeson.

Absolute Antibody Licenses Novel Fc Silencing Technology from mAbsolve

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星期二, 三月 29, 2022

STR, Catalog, Journal, Patent, Research, OXFORD, Immunoglobulin G, PLOS One, Technology, Safety, Knowledge, LALA, PLOS, Antibody, Engineering, Vaccine, FC, REDCAR

REDCAR and OXFORD, United Kingdom, March 29, 2022 /PRNewswire-PRWeb/ -- Absolute Antibody Ltd., an industry-leading provider of recombinant antibody products and services, and mAbsolve, developers of a novel Fc silencing variant, today announced a licensing deal for mAbsolve's Fc silencing technology. The agreement provides Absolute Antibody clients with easy license-free access to the new STR Fc silencing platform for antibody research and development, while ensuring favorable business terms for subsequent clinical development.

Key Points:

REDCAR and OXFORD, United Kingdom, March 29, 2022 /PRNewswire-PRWeb/ -- Absolute Antibody Ltd. , an industry-leading provider of recombinant antibody products and services, and mAbsolve , developers of a novel Fc silencing variant, today announced a licensing deal for mAbsolve's Fc silencing technology.
The agreement provides Absolute Antibody clients with easy license-free access to the new STR Fc silencing platform for antibody research and development, while ensuring favorable business terms for subsequent clinical development.
The license agreement allows Absolute Antibody to make this best-in-class Fc silencing technology available for early-stage therapeutic development and ensures its clients have the best possible starting position for further development of their lead antibody candidates.
The new Fc silencing technology joins Absolute Antibody's full portfolio of antibody engineering capabilities, which also includes species, isotype and subtype switching; chimerization and humanization; and the custom manufacture of bispecific or trispecific antibodies, antibody fragments and Fc fusion proteins.

Alicia Keys Returns to the Apollo to Perform One Night Only Special for SiriusXM and Pandora

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星期五, 十月 22, 2021

The special performance in Keys' hometown is a part of SiriusXM and Pandora's Small Stage Series.

Key Points:

The special performance in Keys' hometown is a part of SiriusXM and Pandora's Small Stage Series.
The concert will also air in its entirety on Alicia Keys' exclusive SiriusXM channel Alicia Keys Radio via satellite (channel 48) and on the SXM App on Friday, December 10 at 8:00 pm ET and PT.
SiriusXM's Alicia Keys Radio will feature music from the GRAMMY Award winner's career, featuring her biggest hits as well as live performances.
SiriusXM and Pandora are offering a chance to win tickets and a trip to New York City to see Alicia Keys perform at the Apollo Theater on November 11, 2021.

UpClear Places on the Inc 5000 List for the 8th Consecutive Year

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星期四, 九月 2, 2021

NEW YORK, Sept. 2, 2021 /PRNewswire-PRWeb/ --Global SaaS company UpClear has placed on the Inc 5000 list for the 8th year in a row.

Key Points:

NEW YORK, Sept. 2, 2021 /PRNewswire-PRWeb/ --Global SaaS company UpClear has placed on the Inc 5000 list for the 8th year in a row.
The Inc 5000 is a list of the fastest growing private companies in the United States, based on a three year cumulative growth.
UpClear made the decision to expand globally at an early stage, developing local expertise and experience in various markets.
"It is an extraordinary achievement to be on the Inc 5000 list for the 8th consecutive year.

LALA Introduces Authentic Hispanic Dessert Products

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星期一, 八月 23, 2021

Supermarket, Retail, Food, Beverage, Consumer, Arroz con leche, Yogurt, Crema (dairy product), Milk, Tres leches cake, Fruit, Time, Multimedia, Grupo Lala, LALA, CEO, Bajaj Consumer Care, Dairy product, Coffee

Dessert-inspired yogurt smoothies and cremas are the newest addition to the LALA brand of fresh dairy products featuring the authentic taste of Mexico.

Key Points:

Dessert-inspired yogurt smoothies and cremas are the newest addition to the LALA brand of fresh dairy products featuring the authentic taste of Mexico.
The new products include three flavors of dessert yogurt smoothies and two flavors of fruit and crema desserts.
The Postres Autnticos family of dessert products are authentic, nourishing and high-quality, said Jorge Ramos, CEO of LALA U.S.
LALA U.S., Inc. is a subsidiary of Grupo LALA, a leading international foods company, with significant operations in Mexico, Brazil, United States, and Central America.