X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home IPR Data Management

Authorities Agree To Work Together Towards Integrating RWE

Content Team by Content Team
1st August 2022
in IPR Data Management, News
Authorities Agree To Work Together Towards Integrating RWE

Real-world evidence (RWE) should be included in regulatory decision-making, according to a declaration backed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The International Coalition of Medicines Regulatory Authorities (ICMRA) released a statement outlining how teamwork between regulators and researchers, which was a key component of the global response to COVID-19, may be used to improve medicine regulation in general.

Real-world data (RWD) and real-world evidence (RWE) are being used more and more in the creation, approval, and tracking of medications to assist regulated decision-making. Even if RWE can be helpful in closing knowledge gaps, there are still issues that must be resolved, such as varied data sources around the world and varying levels of data quality. The different procedures for data access and exchange must also be dealt with by the relevant parties.

ICMRA members promise in their statement to support international initiatives and further facilitate the participation of RWE in regulatory decision-making. They specify four areas of concentration for regulatory collaboration:

  • Harmonization of RWD and RWE terminology
  • Establishing appropriate instances where RWE may assist to regulatory decision-making, as well as regulatory alignment on RWD and RWE recommendations and best practise.
  • Ready to meet new health threats and public health concerns, and
  • Transparency: Establish guidelines for the regular recording of study protocols and findings as well as for encouraging the publication of study findings in open-access, peer-reviewed publications.

The International Conference on Harmonization (ICH), international standardisation bodies, and groups of interested regulators are only a few of the existing sites through which the work in these areas could be advanced. Global regulators stress their commitment to leading this effort.

The joint declaration was created in response to an ICMRA workshop on real-world evidence that the EMA, US FDA, and Health Canada jointly organised and conducted in Amsterdam in June 2022. Participants from more than 40 nations, including WHO members and representatives of the world’s drug regulatory agencies, discussed their successes and difficulties in producing RWE to support the review of pharmaceuticals. International drug regulators discussed specific steps to put the four areas of partnership indicated above into practise.

Previous Post

Airnov to exhibit range of healthcare packaging solutions to Indian market at Innopack Pharma Confex-South

Next Post

Test For Sterility of Cell Culture Using Ratio of NA To NAM

Related Posts

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Drugs Gain From Tardigrade Proteins, Says Research
Drug Development

Pharma Drugs Gain From Tardigrade Proteins, Says Research

22nd March 2023
Next Post
Test For Sterility of Cell Culture Using Ratio of NA To NAM

Test For Sterility of Cell Culture Using Ratio of NA To NAM

Latest News

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In