MWP | Jotup

Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

Retrieved on:

Dienstag, Mai 28, 2024

Knowledge, Real-World Evidence, Selection bias, Commission, Sensitivity analysis, Metadata, Risk, European Medicines Agency, Scope, TTE, FDA, ICES, Vaccine, Answer, MWP, Reflection, Process, Probability, Health care, Community, Interval (mathematics), Hospital, HMA, Applicant (sketch), Data quality, Checklist, Target, Coronary thrombosis, Clutch (eggs), Name, Medicine, User experience, Methodology, CTS, Reproduction, RWD, Annex, Risk assessment, European, Clinical trial, Multi, Moyamoya disease, Data collection, Prognosis, Literature, Health, Trial of the century, Collection, Safety, Marketing, HTA, Research, Cancer, Draft, Incidence, Attention, Isabella Tree, Patient, RWE, ASA, Data, Bias, Guideline, Chapter Six, Prevalence, Diagnosis, Overalls, Big data, Registry, Person, Electronic health record, Good, Area studies, EMA, Drug, MAH, ICH, Classification, Benchmarking, Confounding, CHMP, PASS, Medical imaging

11

Key Points:

11
Reflection paper on use of real-world data in noninterventional studies to generate real-world evidence

12

Table of contents

13

1.
References ............................................................................................ 15
10

Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024

Page 2/16

44

1.
Introduction
45

This reflection paper discusses methodological aspects of non-interventional studies (NIS) using real-

46

world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes.
These include absence of randomisation, uncontrolled conditions, non-
61

standardised treatments and uncertainties regarding data quality and completeness.
The
63

increasing ability to capture electronic healthcare data and data from registries is now providing new

64

opportunities to use RWD and generate RWE that reflects clinical practice.
Scope
89

The scope of this reflection paper is the design, conduct and analysis of NIS using RWD to generate

90

RWE for regulatory purposes.
data collected specifically for the study in
106

question, or secondary use of existing data sources.
In both cases, attention should be paid to the
107

possible selection mechanisms in the data collection, for example the inclusion of specific patients or

108

the collection of specific clinical data.
Reference to studies with causal objectives in this document does not
119

imply an expectation that specific analytical methods will be used.
Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024
Page 4/16

128

The legal obligations and regulatory requirements applicable to NIS should be followed.
138
?

Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of

139
140

personal data and on the free movement of such data.
The specific aim of the study forms the basis for the
164

selection of data source(s), study design, and analysis approach.
Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024
Page 5/16

166

4.2.
Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024
Page 6/16

208

?

Regional differences in clinical practice and healthcare systems management, e.g.
Misclassification can arise at many different
296

steps of data collection and extraction: diagnosis, coding, recording, data transformation, data

297

aggregation, summarisation, and analysis.
Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024
Page 12/16

452

6.4.
For these studies, the study protocol should describe:
456

?

The data elements used to link the data.
Heterogeneity
530

In multi-database studies, different estimates may be found even when the same protocol is applied

531

across all data sources (22).
(2023)
Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024
Page 15/16

569
570

15.
Draft guidance Real-World Data: Assessing Electronic Health Records and Medical Claims
Data To Support Regulatory Decision-Making for Drug and Biological Products (2021)
571
572
573

16.
Reflection paper on use of real-world data in non-interventional studies to generate
real-world evidence
EMA/CHMP/150527/2024
Page 16/16

solutions by stc signs an Open RAN Agreement with Mavenir to Launch First Commercial Open RAN in Saudi Arabia

Retrieved on:

Dienstag, Februar 27, 2024

solutions by stc, the leading enabler of digital transformation in Saudi Arabia and the region, announces an Open RAN agreement with Mavenir, the cloud-native network infrastructure provider building the future of networks, to launch the first commercial Open RAN network in Saudi Arabia.

Key Points:

solutions by stc, the leading enabler of digital transformation in Saudi Arabia and the region, announces an Open RAN agreement with Mavenir, the cloud-native network infrastructure provider building the future of networks, to launch the first commercial Open RAN network in Saudi Arabia.
View the full release here: https://www.businesswire.com/news/home/20240226664170/en/
Signing ceremony at Mobile World Congress (MWC) on stc stand in Hall 3.
Executive company representatives: Yousef Almarshad, Chief Commercial Officer at solutions by stc & Pardeep Kohli, Chief Executive Office at Mavenir.
The solution will run on x86 commercial-off-the-shelf (COTS) hardware platform that represents best-in-class technology for open interface radio systems.

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

Retrieved on:

Mittwoch, Februar 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

Page 2/14

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

Page 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/58124/2023
Page 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/58124/2023
Page 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)
EMA/CHMP/58124/2023
Page 6/14

?

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
Page 7/14

?

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
Page 8/14

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
Page 9/14

?

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
Page 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)
EMA/CHMP/58124/2023
Page 11/14

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
Page 12/14

?

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

Page 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)
EMA/CHMP/58124/2023
Page 14/14

Beer Institute Lauds Introduction of Bill to Prevent Unfair Tariff Charges on Aluminum

Retrieved on:

Montag, Januar 29, 2024

MWP, Legislation, Beer, Public policy, Policy, Aluminium, CO-04, Government, Beer Institute, False Claims Act, Consumer Brands Association, Accusative case, Midwestern United States, Pharmaceutical industry

Aluminum is the single largest input cost in brewing, and the lack of transparency in aluminum pricing hurts consumers.

Key Points:

Aluminum is the single largest input cost in brewing, and the lack of transparency in aluminum pricing hurts consumers.
Imported primary aluminum and cansheet are critical to the U.S. beer industry as more than 74 percent of all beer produced in the United States is packaged in aluminum cans and bottles.
In 2020, brewers bought more than 41 billion aluminum cans and bottles, making aluminum the single most significant input cost in American beer manufacturing.
For additional updates from the Beer Institute, visit our website and follow us on X , LinkedIn , Facebook and Instagram .

New Research Shows Tariffs on Aluminum Have Cost the U.S. Beverage Industry Nearly $2.2 Billion

Retrieved on:

Dienstag, Dezember 5, 2023

Beer Institute, Public policy, MWP, Aluminium, Research, Beer, Midwestern United States, Chin

In the nearly six years since Section 232 tariffs on aluminum were imposed, the American beverage industry has paid more than $2.175 billion in unnecessary fees.

Key Points:

In the nearly six years since Section 232 tariffs on aluminum were imposed, the American beverage industry has paid more than $2.175 billion in unnecessary fees.
The research conducted by HARBOR Aluminum on behalf of the Beer Institute found that the U.S. beverage industry paid $2.175 billion in Section 232 tariffs on 10.295 million metric tons of aluminum since their implementation.
“After almost six years, the American beverage industry has paid nearly $2.2 billion in unnecessary fees since Section 232 tariffs on aluminum were implemented,” said Brian Crawford, president and CEO of the Beer Institute.
In 2020, brewers bought more than 41 billion aluminum cans and bottles, making aluminum the single most significant input cost in American beer manufacturing.

Beer Institute Launches MidwestPremiumExposed.org to Shine a Light on Shady Aluminum Pricing

Retrieved on:

Montag, November 20, 2023

Beer Institute, Public policy, MWP, Aluminium, Beer, Research, Midwestern United States, Letter, Recycling

The MWP is a dubious pricing system that allows aluminum producers to charge end-users a tariff on non-tariffed metal.

Key Points:

The MWP is a dubious pricing system that allows aluminum producers to charge end-users a tariff on non-tariffed metal.
Aluminum producers are able to engage in this questionable behavior because there is currently no regulatory body overseeing the usage of the MWP.
“The Midwest Premium has evolved into a black box that artificially drives up the price of aluminum for end-users, including the maker of your favorite beer," said Brian Crawford, president and CEO of the Beer Institute.
For additional updates from the Beer Institute, visit our website , follow @BeerInstitute on Twitter, like the Beer Institute on Facebook , and follow the Beer Institute on Instagram .

Ice Norway Upgrades to Mavenir’s Cloud-Native IMS on Red Hat OpenShift in Strategic Project Expansion

Retrieved on:

Mittwoch, Oktober 18, 2023

This strategic project expansion, being delivered in collaboration with Red Hat, positions Mavenir as the complete data and voice core partner for Ice Norway.

Key Points:

This strategic project expansion, being delivered in collaboration with Red Hat, positions Mavenir as the complete data and voice core partner for Ice Norway.
The engagement of Mavenir to now replace the incumbent IMS provider, completes Ice Norway’s migration to cloud-native state-of-the-art technology, and enables Ice to provide market-leading 5G services.
Red Hat OpenShift offers a fast, flexible and easy-to-manage platform that can speed up application development, accelerate deployment, and extend control over distributed resources.
By combining Red Hat’s powerful cloud infrastructure and application platform with Mavenir’s cloud-native IMS solution, Ice Norway can more easily and quickly modernize its network functions to deploy 5G applications anywhere for enhanced business results.”

How analyzing ancient and modern polar bear samples reveals the full scope of global warming

Retrieved on:

Freitag, September 1, 2023

These are objectively true statements that most people have come to accept.

Key Points:

These are objectively true statements that most people have come to accept.
But it is also true that Earth’s climate has never been stagnant and climate anomalies have been frequent throughout the past.
Are the impacts of modern climate change comparable to those of the medieval warm period (MWP) or the little ice age (LIA)?

Ecosystem background

Predators at the top of the food chain, like polar bears, reflect changes across the entire ecosystem, all the way down to microscopic algae.
In the Arctic, the base of the food web is sourced from two categories: sea ice-associated algae and open-water phytoplankton, which are distinguishable through their carbon isotopes.

Results from our study

In our study we examined stable carbon and nitrogen isotopes in polar bear bone collagen.
The polar bears were all from the Lancaster Sound sub-population and spanned the last 4,000 years.

What it all means

The results of the nitrogen isotopes showed that throughout time, 4,000 years BP to the present, the structure of the Lancaster Sound food web was relatively unchanged.
Polar bears eat seals, seals eat cod, cod eat zooplankton, et cetera.
There were no surprising shifts in the diets of polar bears despite past and present climate change.

Evidence of a warming climate

For ringed seals, the primary prey of polar bears, it is a platform for denning and raising young.
In this case, we have illustrated the magnitude of difference occurring in the modern Arctic, relative to past climate anomalies.
We can, therefore, not dismiss calls to action on climate change on the basis that the climate has always fluctuated.

LPL Adds Direct Indexing to Its Model Wealth Portfolios Platform

Retrieved on:

Samstag, August 5, 2023

SMA, LPL Financial, Spinal muscular atrophies, EAFE, Research, LPL, MWP, Financial services, Financial adviser, MSCI

CHARLOTTE, N.C., Aug. 05, 2023 (GLOBE NEWSWIRE) -- LPL Financial today announced the availability of direct indexing within the firm’s Model Wealth Portfolios (MWP) unified managed account program.

Key Points:

CHARLOTTE, N.C., Aug. 05, 2023 (GLOBE NEWSWIRE) -- LPL Financial today announced the availability of direct indexing within the firm’s Model Wealth Portfolios (MWP) unified managed account program.
The new strategy was announced at LPL’s flagship event for financial professionals, Focus 2023, held from August 4 to August 7 in San Diego, CA.
Direct indexing can help make trading investment strategies more tax efficient, while also creating personalized outcomes for clients, which benefits advisors and investors alike.
"Utilizing direct indexing capabilities can also help to attract and retain investors looking for sophisticated and personalized investment advice."

Siegel-WisdomTree Longevity and Siegel-WisdomTree Global Equity Models Now Available on LPL’s Model Wealth Portfolios Platform

Retrieved on:

Donnerstag, Juni 29, 2023

WisdomTree, Inc. (NYSE: WT), a global financial innovator, announced that its Siegel-WisdomTree Longevity and Siegel-WisdomTree Global Equity Models are now available on LPL Financial’s unified managed account platform Model Wealth Portfolios (MWP).

Key Points:

WisdomTree, Inc. (NYSE: WT), a global financial innovator, announced that its Siegel-WisdomTree Longevity and Siegel-WisdomTree Global Equity Models are now available on LPL Financial’s unified managed account platform Model Wealth Portfolios (MWP).
“Joining the Model Wealth Portfolios Platform marks an exciting new chapter in WisdomTree and LPL’s relationship.
Siegel-WisdomTree Global Equity Model Portfolio:
Seeks to provide a diversified exposure to U.S. and International stocks and tilts toward the same factors as the Longevity Model.
He serves on the Model Portfolio Investment Committee for the Siegel-WisdomTree Model Portfolios of WisdomTree, which develops and rebalances WisdomTree's Model Portfolios.