Mutual Recognition Agreements and Reliance in the Regulation of Medicines

Webinar

Mutual Recognition Agreements in the Regulation of Medicines: Regulatory Reliance— If not now, when? What are the current barriers?

September 4, 2020

10:30 AM - 12:00 PM (ET)

Past

Materials

About

This Webinar will focus on the barriers to greater use of regulatory reliance during the pandemic by drawing upon messages from the recently released the National Academies report on regulatory reliance that was funded by FDA’s Office of Global Policy and Strategy. This Webinar will focus on the barriers to greater use of regulatory reliance during the pandemic by drawing upon messages from the recently released the National Academies report on regulatory reliance that was funded by the FDA’s Office of Global Policy and Strategy.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Hannah Goodtree

(202) 334-1471
hgoodtree@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Webinar

Report Release Webinar: Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators

November 21, 2019

9:00 AM - 10:00 AM (ET)

Past

About

On November 21, 2019, at 9 am ET (2 pm GMT), Please join us for the report release webinar of the new National Academies report, Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. The webinar will include an overview of the report and discussion of the report’s findings, recommendations, and key messages.

Register here to watch the webinar release of the new report.

*** The direct webinar link and password will be emailed to you upon completing the eventbrite registration***

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 13

July 29, 2019

11:00 AM - 12:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Monday, July 29th, 2019 through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Webcast

Meeting 3: Mutual Recognition Agreements in the Regulation of Medicines

July 10, 2019

9:00 AM - 4:00 PM (ET)

Past

Materials

About

July 10, 2019 from 8:30am - 4:00pm (British Standard Time)

In this public session of information gathering, regulatory leaders will share challenges and opportunities for improving the exchange of information between national/regional regulatory authorities, the use of exchanged information, and the scope of exchanged information. Presentations will be 8-10 min each and guided by the following questions:

Challenges with the exchange of information between regulators and how they have/have not been addressed: How could things work better and what needs to be done?
Challenges in using exchanged information in informing their own regulatory decisions and how they have/have not been addressed: How could things work better and what needs to be done?
Opportunities for increasing the scope of regulatory activities (beyond GMP inspection reports) that would be/have been amenable to reliance on exchanged information : Are there specific areas that would be/have been relatively easy to address (e.g., API/GCP/GLP inspections; laboratory analyses for various regulatory purposes; PSUR assessment reports, bioequivalence study assessment reports, animal toxicology assessment reports, microbiology assessment reports; others)

The presentations will be followed by a facilitated conversation, by committee members.

To join the meeting: https://www.bethereglobal.com/nas-071019

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

Alastair Wood, David Beier, Thomas Bollyky, Katherine Bond, Martha Brumfield, David Cockburn, Elizabeth
Golberg, Lawrence Gostin, Gavin Huntley-Fenner, Barbara Koremenos, Murray Lumpkin, Lembit Rägo

The following topics were discussed in the closed sessions:

The meeting began with the chair providing opening remarks before opening the meeting to a public
information-gathering session. After the open session, the committee debriefed on what they had learned.
The committee then discussed what further information they need in order to answer the statement of task,
and discussed strategies for obtaining that information. The committee worked on filling out the structure and
main themes of the report, and the closed session concluded after a discussion on the structure.

The following materials (written documents) were made available to the committee in the closed sessions:

A briefing book with no articles included

Date of posting of Closed Session Summary:

July 26, 2019

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 4

May 29, 2019

9:30 AM - 10:30 AM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines will meet on Wednesday, May 29th, 2019through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting Closed

Meeting 4: Mutual Recognition Agreements in the Regulation of Medicines

September 9 - 10, 2019

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

David Beier, Thomas Bollyky, Katherine Bond, Martha Brumfield, David Cockburn, Lawrence Gostin, Gavin Huntley-Fenner, Barbara Koremenos, Lembit Rägo, Alastair Wood

The following topics were discussed in the closed sessions:

The committee had a discussion of how the report writing is going. The committee then discussed how to frame their recommendations. The committee returned for a second day, to further discuss and finalize the report recommendations.

The following materials (written documents) were made available to the committee in the closed sessions:

A draft of the report and recommendations were provided to the committee.

Date of posting of Closed Session Summary:

November 22, 2019

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 14

August 2, 2019

11:00 AM - 12:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Friday, August 2nd, 2019 through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 12

July 24, 2019

7:30 PM - 8:30 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Wednesday, July 24th, 2019 through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 11

June 26, 2019

9:00 AM - 10:00 AM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Wednesday, June 26th, 2019 through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 10

June 11, 2019

11:00 AM - 12:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Tuesday, June 11th, 2019 in person and through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 9

June 10, 2019

6:00 PM - 7:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines will meet on Monday, June 10th, 2019through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 8

June 10, 2019

1:00 PM - 2:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Monday, June 10th, 2019 through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 7

June 10, 2019

11:00 AM - 12:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Monday, June 10th, 2019through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 6

June 7, 2019

11:30 AM - 12:30 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines will meet on Friday, June 7th, 2019 through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 5

May 31, 2019

1:00 PM - 3:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Friday, May 31st, 2019through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 3

May 28, 2019

10:00 AM - 11:00 AM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Tuesday, May 28th, 2019 in person and through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 2

May 7, 2019

11:00 AM - 12:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Tuesday, May 7th, 2019through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Tele Conference

Mutual Recognition Agreements and Reliance in the Regulation of Medicines Information Gathering Session: Meeting 1

May 3, 2019

11:00 AM - 12:00 PM (ET)

Past

Agenda

Download the Agenda

About

The Committee on Mutual Recognition Agreements in the Regulation of Medicines will meet on Friday, May 3rd, 2019through virtual conference. This meeting will provide an opportunity for the committee to hear and gather information from invited subject matter experts.

Please email Kelly Choi (KChoi@nas.edu) to register for this event.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Kelly Choi

(202) 334-3194
kchoi@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Meeting 2: Mutual Recognition Agreements in the Regulation of Medicines

April 1, 2019

1:00 PM - 4:00 PM (ET)

Past

Materials

Meeting Summary

About

In this public session of information gathering, regulatory leaders will share their perspectives regarding their motivations and process for pursuing recognition and reliance mechanisms in drug regulation, especially mutual recognition agreements. Presentations will be 20 min each and guided by the following questions:

Initiation

What were the motivations to pursuing and/or entering into an agreement?
What types of information or decisions were to be relied upon or recognized?
How did you approach the protection of sensitive information?
What benefits, costs, and risks did you forsee before entering into an agreement?

Implementation and Impacts

What have been some major challenges and opportunities when implementing agreements?
What have been the benefits, costs, and challenges resulting from the agreement for:
- public health?
- regulatory efficiencies and the ability to redirect resources?
- regulatory expertise and competencies?
- economics?

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

Alastair Wood, David Beier, Thomas J. Bollyky, Katherine Bond, Martha Brumfield, David Cockburn, Elizabeth Golberg, Gavin Huntley-Fenner, Barbara Koremenos, Murray Lumpkin, Lembit Rägo

The following topics were discussed in the closed sessions:

Information gathering and report writing strategies.

The following materials (written documents) were made available to the committee in the closed sessions:

Publicly accessible articles on mutual recognition agreements.

Contact

Daniel Flynn

(202) 334-2667
dflynn@nas.edu

Location

National Academy of Sciences Building

2101 Constitution Ave NW

Washington DC 20418, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Meeting 1: Mutual Recognition Agreements in the Regulation of Medicines

February 4, 2019

1:00 PM - 2:45 PM (ET)

Past

Materials

Meeting Summary

Additional Information

Is it a Closed Session event?

Partially Closed

Contact

Natalie Lubin

(202) 334-2832
nlubin@nas.edu

Location

National Academy of Sciences Building

2101 Constitution Ave NW

Washington DC 20418, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Mutual Recognition Agreements and Reliance in the Regulation of Medicines

Dropdown items

Mutual Recognition Agreements in the Regulation of Medicines: Regulatory Reliance— If not now, when? What are the current barriers?

Report Release Webinar: Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators