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Study: Eating almonds may help lower CVD risk factors and associated healthcare costs

A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.




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How APEC Helps Small Business Go Global

From access to capital to dispute resolution.




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Digital Transformation is Vital for Small Businesses

“Ten, twenty, thirty years ago, you were in the best position to go global if you were a large company and had a lot of resources and access to a lot of attorneys and advisors who could help you navigate regulations and issues that get more complicated as you go abroad.”




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APEC SME Ministers Commit to Inclusion Through Digital Transformation

Ministers convened this week in Concepcion to talk about one of the most underrepresented but vital business sectors of the region.




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APEC Small and Medium Enterprises Ministers Issue Joint Statement

Ministers in charge of small and medium enterprises (SMEs) in the APEC region issued a statement following their meeting in Concepcion, Chile, on 5-6 September 2019.




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Wanted: Data on the Gender Gap, Digital Divide and Small Businesses

We need it for inclusive policymaking




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Chile Joins APEC Efforts to Bolster Health Ethics, Support SMEs and Patients

APEC continues to bolster ethics in the healthcare sector in support of small and medium enterprises (SMEs) and patients, as Chile launches a consensus framework to improve ethical interactions in its healthcare system.




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Promoting Universal Health Coverage: Sharing a Prosperous and Healthy Future

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.




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Finalists of APEC Healthy Women, Healthy Economy Prize Announced

Equal pay, migrant workers, and maternal health are the issues highlighted by the finalists of the inaugural APEC Healthy Women, Healthy Economies Research Prize.




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Inaugural Healthy Women Health Economies Prize Announces Winning Research

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.




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Women Entrepreneurs and Managers Win 2019 APEC BEST Award

APEC officials announced this year’s winners for the annual APEC Business Efficiency and Success Target Awards, or BEST Awards - a collection of some of the best women-led businesses in the Asia-Pacific region.




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Women Advancing in APEC Region but More Reforms Needed

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.




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APEC Ministers in Charge of Women’s Economic Participation Issue Joint Statement

Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019.




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APEC Economies Agree on Principles and Actions to Support Women in Science, Technology, Engineering, and Mathematics

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.




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APEC Finance Ministers Call for Economic Resilience and Financial Inclusion

Ministers address developments in the global economy and take action to safeguard the region’s growth.




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APEC Finance Ministers Issue Ministerial Statement

Finance Ministers from APEC member economies issued a joint statement reflecting the outcomes of the APEC Finance Ministers’ Meeting in Santiago, Chile, chaired by Chile’s Minister of Finance Felipe Larrain.




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Inclusive Growth is Top of APEC’s Agenda

Media registration is open for the APEC Concluding Senior Officials’ Meeting to take place on 7 December 2019 at the APEC Secretariat in Singapore.




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Malaysia to Lead APEC in 2020 in Fostering Shared Prosperity

Media Registration is Open for the APEC Informal Senior Officials’ Meeting




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Consensus Fosters Sustainable and Inclusive Growth: APEC Senior Officials

Members of the Asia-Pacific Economic Cooperation (APEC) will continue to work together towards more inclusive and sustainable growth, pledged APEC Senior Officials at the concluding event for Chile’s host year of APEC.




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Winner of 2019 APEC Photo Contest Also Wins Popular Choice Award

The winner of the APEC Photo Contest 2019 has also won the most votes for the Popular Choice Award, announced the APEC Secretariat.




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Chinese Taipei Adds Contribution for Inclusive Growth Initiatives

Chinese Taipei has voluntarily contributed USD 550,000 in funding to support APEC initiatives that advance regional economic integration and inclusive sustainable growth across the Asia-Pacific.




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Technology Opens Doors, say Winners of APEC Digital Prosperity Award

A duo of innovative programmers from Malaysia are the winners of the 2019 APEC Digital Prosperity Award, announced on the sidelines of the APEC Informal Senior Officials’ Meeting in Langkawi.




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Policies Must Ensure Inclusion and Sustainability: APEC Malaysia 2020

Broaden opportunities for people and ensure more inclusive growth across the Asia-Pacific, urged the 2020 Chair of APEC Senior Officials, host of the Asia-Pacific Economic Cooperation in 2020.




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Towards Shared Prosperity: Malaysia Begins Host Year in Putrajaya

Media registration is open for the First APEC Senior Officials’ Meeting (SOM1) and related meetings in Putrajaya, Malaysia from 3 February to 22 February 2020.




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APEC to Bring a New Vision in 2020

APEC’s 21 member economies will finalize in 2020 a new vision for the forum’s next phase, said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria.




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APEC Advances Digitization of the APEC Business Travel Card

An APEC Business Travel Card mobile application will make travel easier and more secure




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ABAC Release: Achieving Integration and Inclusion in the Age of Disruption

Business leaders from around the Asia-Pacific met in Sydney last week to discuss the year ahead




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APEC Healthy Women Prize Accepting Applications

Research Promoting Women’s Health to Receive $20,000 Prize




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Gathering in Putrajaya Opens Year of Optimizing Human Potential

The first Senior Officials Meeting for APEC Malaysia 2020 begins




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APEC Needs to Look Beyond Numbers, Bring Concrete Benefits to People

Enable trade and investments to generate concrete outcomes for the people.




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Software Developers Invited to Join 2020 APEC App Challenge

The challenge: Innovative mobile apps and platforms that empower the aging society




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Regional Dialogue during an Outbreak

“I would like to express our appreciation to APEC member economies that put their faith in Malaysia’s leadership and made it a point to participate.”




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Tapping the Economic Potential of Women

La Serena Roadmap for Women and Inclusive Growth to bolster progress




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APEC Announces Postponement of Upcoming Ministerial Meetings

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.




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APEC Health Working Group Statement on COVID-19

Reflecting the discussions of the Health Working Group which met at the First APEC Senior Officials Meeting, 7-8 February 2020, Putrajaya, Malaysia




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APEC Collaboration the First-best Strategy to Combat COVID-19, Says Business

Business leaders from the Asia-Pacific region called for APEC leadership and cooperation to combat the grave challenges to health and economies posed by the COVID-19 pandemic.




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APEC Faces USD 2.1 Trillion in Output Loss to COVID-19

Regional cooperation key to containment and rebound




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Promoting Trade in Medical Goods Will Save Lives

Medical supplies and personal protective products are facing barriers worldwide




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APEC Ministers Responsible for Trade Issue Statement on COVID-19

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.




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RE: Reporting the Purchase of a Med Device Company to the FDA

From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]




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RE: Topical gel Syringe change - plastic to glass

From : Communities>>Regulatory Open Forum
Dear Roy, You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact. The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which [More]




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RE: New: Take the RAC Exams Online this Summer!

From : Communities>>Regulatory Open Forum
Great! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------




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RE: Sort It Out by participating in the RAPS Tagging Project

From : Communities>>Regulatory Open Forum
Hi everyone, I just finished it, and it is a really simple task! Go ahead! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------




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RE: Guidance for off-label use of medical devices in Canada (Health Canada)?

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------




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RE: Guidance for off-label use of medical devices in Canada (Health Canada)?

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------





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RE: Upcoming Chicago Chapter Webcast with Dr. Bassil Akra

From : Communities>>Regulatory Open Forum
Hi Annie, I knew before that I wouldn't be able to attend to the webcast, so I did not register for it. But I am very curious on Dr. Akras insights. Is it possible to view a recording of it? Thanks, Britta ------------------------------ Britta Cyron Bochum Germany ------------------------------




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RE: Topical gel Syringe change - plastic to glass

From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant




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EUA Timeline

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Hello, Does anyone know how long FDA's EUA process takes for approval compared to a 510k.  EUA seems to ask a lot of the same information that a 510k requests so not clear on what the benefits are or if it's worthwhile.  I assume you will eventually have to achieve traditional market clearance at some point. Any insight would be most appreciated. Thank you.




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RE: Sort It Out by participating in the RAPS Tagging Project

From : Communities>>Regulatory Open Forum
Thank you all for participating in our Tagging Project! We're glad to hear you enjoyed it. All volunteers were entered into a drawing for a $50 Amazon gift card. See a video of the drawing attached.  I'm happy to announce that the winner is ...  @Jonathan Amaya-Hodges ! Thanks again to all who participated. If you're interested in more volunteer opportunities, see our full list here .​​ ------------------------------ Danielle Fezell Manager, Chapter & Volunteer Relations, RAPS Rockville MD United [More]

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RE: Sort It Out by participating in the RAPS Tagging Project