"Dossier in the Cloud" Democratizing Global Access

FromDIA: Driving Insights to Action

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"Dossier in the Cloud" Democratizing Global Access

FromDIA: Driving Insights to Action

ratings:

Length:

3 minutes

Released:

Apr 2, 2024

Format:

Podcast episode

Description

Accumulus Synergy CEO Francisco Nogueira shares expectations for the outcomes of a post-approval changes pilot led by Roche which utilizes the Accumulus platform and follows WHO principles of good regulatory reliance practices.

Released:

Apr 2, 2024

Format:

Podcast episode

Titles in the series (20)

DIA is a global, multidisciplinary, membership association of healthcare professionals that works towards the advancement of lifesaving medicines, therapies, and technologies around the world.

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What We Are Missing by Not Including ”Who?”: In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all co... by DIA: Driving Insights to Action
13 min listen
Medication Errors Emerge as Global Patient Safety Issue by DIA: Driving Insights to Action
43 min listen
WHO Pilot Formalizes CSA Process to Assist Developers: The World Health Organization has initiated a pilot coordinated scientific advice (CSA) procedure whereby product developers may obtain WHO advice on the most appropriate way to generate evidence on a product's benefits and risks. “WHO has been interacti... by DIA: Driving Insights to Action
15 min listen
Cancer Data Ecosystem Powering Moonshot Relaunch by DIA: Driving Insights to Action
18 min listen
China Sets New Record for Local Drug Approvals in 2021: DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs an... by DIA: Driving Insights to Action
17 min listen
Digital Revolutionizing Data-Driven Reimbursement by DIA: Driving Insights to Action
27 min listen
Why Trans/Nonbinary Research Benefits All Communities: Actions to increase patient diversity in clinical research initially addressed racial and ethnic demographics but are expanding to address gender identity. “Further research can only help us better understand the differences in our bodies and illness... by DIA: Driving Insights to Action
35 min listen
Australian Clinical Trials Alliance Part 1 – Current Perceptions: “The pandemic had a substantial impact on community understanding of clinical trials. Having said that, the sort of ambient level of community knowledge of clinical trials is still substantially lower than it needs to be,” explains Australian Clinica... by DIA: Driving Insights to Action
13 min listen
Looking Back and Ahead: Translational Science Advances Impacting Patient Care: From microphysiological systems and digital pathology to next-generation-sequencing and diversity in foundational genomic data sets: In this iteration of our annual year in review podcast, Global Forum Co-Editors for Translational Science Gary Kellof... by DIA: Driving Insights to Action
29 min listen
Rwanda Welcomes African Medicines Agency Home: While the African Medicines Agency (AMA) plans and plants its inaugural headquarters in Rwanda, the European Commission, the European Medicines Agency (EMA), several EU Member States, and the Bill and Melinda Gates Foundation continue to mobilize mor... by DIA: Driving Insights to Action
43 min listen
DIA: A Place Where You Can Make a Difference: Listen to former DIA Board President Minnie Baylor-Henry’s special message to DIA members as part of DIA’s 60th Anniversary celebration in 2024. by DIA: Driving Insights to Action
2 min listen
Will Technology Solve the Research “People Problem”?: Clinical trials struggle to enroll eligible patients, while interested patients have difficulty finding pertinent clinical trials. Can technology help solve this people problem? “Typical patient recruitment happens based on historical data at researc... by DIA: Driving Insights to Action
20 min listen
Project Architect Explains New ANVISA Online Optimized Assessment: For regulators in Brazil, the pandemic’s aftermath includes a backlog of post-approval changes, delayed by emergency development of COVID-19 vaccines and therapies, related to biologic product quality. ANVISA’s new Online Optimized Assessment Project... by DIA: Driving Insights to Action
15 min listen
Patient Engagement: Evolution of Who Knows What, Part 1: DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement in clinical research and care with cancer survivors and “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy ... by DIA: Driving Insights to Action
18 min listen
Australian Clinical Trials Alliance Part 2 – Future Projections: “Healthcare systems obviously have as their primary role the delivery of healthcare,” says Steve Webb, Australian Clinical Trials Alliance board chair. “But we can see big improvements in health outcomes, combined with substantially better financial ... by DIA: Driving Insights to Action
15 min listen
Autumn’s Leukemia Story: Regimens, Recovery, and Realizations: A few years ago, 8-year-old Autumn noticed a lump on the side of her neck as she was preparing for bed one night. That quiet night opened a new chapter not only in Autumn’s life but in the life of her entire family: Autumn had leukemia. In this inter... by DIA: Driving Insights to Action
20 min listen
Retiring TGA Head Maps Australia’s Post-Pandemic Future: In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. “What's really changed and what will ... by DIA: Driving Insights to Action
18 min listen
Patient Engagement: Evolution of Who Knows What, Part 2: In part two of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research and care with DIA GAM 2023 Patient Engagement track chai... by DIA: Driving Insights to Action
14 min listen
"Dossier in the Cloud" Democratizing Global Access: Accumulus Synergy CEO Francisco Nogueira shares expectations for the outcomes of a post-approval changes pilot led by Roche which utilizes the Accumulus platform and follows WHO principles of good regulatory reliance practices. by DIA: Driving Insights to Action
3 min listen
GPP Experts Explain Authorship Algorithm: Good Publication Practice (GPP) experts explain the authorship algorithm designed to weigh each author's contribution relative to other authors' contributions in a study, and to define appropriate ways to establish the authorship byline. by DIA: Driving Insights to Action
8 min listen

More Episodes from DIA: Driving Insights to Action

Skip carousel

GPP Experts Explain Authorship Algorithm: Good Publication Practice (GPP) experts explain the authorship algorithm designed to weigh each author's contribution relative to other authors' contributions in a study, and to define appropriate ways to establish the authorship byline. by DIA: Driving Insights to Action
8 min listen
DIA: A Place Where You Can Make a Difference: Listen to former DIA Board President Minnie Baylor-Henry’s special message to DIA members as part of DIA’s 60th Anniversary celebration in 2024. by DIA: Driving Insights to Action
2 min listen
Autumn’s Leukemia Story: Regimens, Recovery, and Realizations: A few years ago, 8-year-old Autumn noticed a lump on the side of her neck as she was preparing for bed one night. That quiet night opened a new chapter not only in Autumn’s life but in the life of her entire family: Autumn had leukemia. In this inter... by DIA: Driving Insights to Action
20 min listen
Retiring TGA Head Maps Australia’s Post-Pandemic Future: In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. “What's really changed and what will ... by DIA: Driving Insights to Action
18 min listen
Patient Engagement: Evolution of Who Knows What, Part 2: In part two of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research and care with DIA GAM 2023 Patient Engagement track chai... by DIA: Driving Insights to Action
14 min listen
Patient Engagement: Evolution of Who Knows What, Part 1: DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement in clinical research and care with cancer survivors and “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy ... by DIA: Driving Insights to Action
18 min listen
Australian Clinical Trials Alliance Part 2 – Future Projections: “Healthcare systems obviously have as their primary role the delivery of healthcare,” says Steve Webb, Australian Clinical Trials Alliance board chair. “But we can see big improvements in health outcomes, combined with substantially better financial ... by DIA: Driving Insights to Action
15 min listen
Project Architect Explains New ANVISA Online Optimized Assessment: For regulators in Brazil, the pandemic’s aftermath includes a backlog of post-approval changes, delayed by emergency development of COVID-19 vaccines and therapies, related to biologic product quality. ANVISA’s new Online Optimized Assessment Project... by DIA: Driving Insights to Action
15 min listen
Australian Clinical Trials Alliance Part 1 – Current Perceptions: “The pandemic had a substantial impact on community understanding of clinical trials. Having said that, the sort of ambient level of community knowledge of clinical trials is still substantially lower than it needs to be,” explains Australian Clinica... by DIA: Driving Insights to Action
13 min listen
Looking Back and Ahead: Translational Science Advances Impacting Patient Care: From microphysiological systems and digital pathology to next-generation-sequencing and diversity in foundational genomic data sets: In this iteration of our annual year in review podcast, Global Forum Co-Editors for Translational Science Gary Kellof... by DIA: Driving Insights to Action
29 min listen
Rwanda Welcomes African Medicines Agency Home: While the African Medicines Agency (AMA) plans and plants its inaugural headquarters in Rwanda, the European Commission, the European Medicines Agency (EMA), several EU Member States, and the Bill and Melinda Gates Foundation continue to mobilize mor... by DIA: Driving Insights to Action
43 min listen
Will Technology Solve the Research “People Problem”?: Clinical trials struggle to enroll eligible patients, while interested patients have difficulty finding pertinent clinical trials. Can technology help solve this people problem? “Typical patient recruitment happens based on historical data at researc... by DIA: Driving Insights to Action
20 min listen
Why Trans/Nonbinary Research Benefits All Communities: Actions to increase patient diversity in clinical research initially addressed racial and ethnic demographics but are expanding to address gender identity. “Further research can only help us better understand the differences in our bodies and illness... by DIA: Driving Insights to Action
35 min listen
Digital Revolutionizing Data-Driven Reimbursement by DIA: Driving Insights to Action
27 min listen
China Sets New Record for Local Drug Approvals in 2021: DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs an... by DIA: Driving Insights to Action
17 min listen
WHO Pilot Formalizes CSA Process to Assist Developers: The World Health Organization has initiated a pilot coordinated scientific advice (CSA) procedure whereby product developers may obtain WHO advice on the most appropriate way to generate evidence on a product's benefits and risks. “WHO has been interacti... by DIA: Driving Insights to Action
15 min listen
Medication Errors Emerge as Global Patient Safety Issue by DIA: Driving Insights to Action
43 min listen
What We Are Missing by Not Including ”Who?”: In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all co... by DIA: Driving Insights to Action
13 min listen
Cancer Data Ecosystem Powering Moonshot Relaunch by DIA: Driving Insights to Action
18 min listen

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Discover this podcast and so much more

"Dossier in the Cloud" Democratizing Global Access

"Dossier in the Cloud" Democratizing Global Access

Description

Titles in the series (20)

More Episodes from DIA: Driving Insights to Action

Related podcast episodes