The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
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Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
Lik Medical Device made Easy Podcast
How do I start an online business? How do I build a brand online? How do I get traffic and attention to my online business? The biggest question is, can I start a business online and replace my current JOB? Welcome to The Rock Your Brand podcast show where we answer ALL of these questions and a ton MORE! Scott Voelker, the host will share with you everything you need to know and help you to build a Future Proof Business that will allow you the ultimate Freedom. Scott shares tips and strategi ...
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Kipp Bodnar (HubSpot’s CMO) and Kieran Flanagan (Zapier’s CMO), lead you down the rabbit hole of marketing trends, growth tactics and innovation. On the way you’ll pick up undiscovered strategies to give you that slight edge for success. These are not your typical twitter thread regurgitated marketing tactics that everyone is doing. These are new methods, with unfiltered examination of successful fresh ideas.
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Radio Advisory is your weekly download on how to untangle healthcare's most pressing challenges, powered by 40 years of Advisory Board research. Whether it's workforce shortages, industry disruptors, or health equity strategy, we're here to help. Our hosts and seasoned researchers talk with industry experts to equip you with knowledge to confront today’s unanswered questions in healthcare. New episodes drop every Tuesday. | www.advisory.com
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The Brutal Truth about Sales and Selling - We interview the world's best B2B Enterprise salespeople.
Brian Burns
No BS Allowed - Are you sick of empty suits telling you to work harder? - Learn about The Maverick Selling Method, which models the world's best salespeople and what they do differently. If you are in sales and are passionate about selling, you will like this podcast. The focus is on b2b sales and selling. If you are selling or in sales, this podcast is for you. I cover cold calling, spin selling, challenger sale, solution selling, and advanced selling skills. Strategic selling, LinkedIn, sa ...
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Welcome to an exciting new season of the podcast Your Career: Choice or Chance? - as we dive into the ever-evolving world of GenAI in the Workplace and explore the latest trends, experiences, and career journeys shaping the future of work as AI is increasingly ingrained in it. Each episode provides fresh insights, addressing the transformative influence of GenAI in shaping the workforce of tomorrow, making it a must-listen for anyone interested in staying ahead in the ever-evolving world of ...
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The American healthcare system is one of the most innovative in the world. But it’s also riddled with complex challenges, such as access to affordable medications, inefficiency and administrative burdens, and communication barriers between providers. There’s clearly a better way—and at Surescripts, we have a unique sightline into what that may be. In this series, host Melanie Marcus, Chief Marketing Officer of Surescripts, sits down with today’s most inspiring and innovative leaders in healt ...
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Tired of management theory? Want to learn specific skills to help improve your management performance? Then Manager Tools is the podcast for you! Manager Tools is a weekly business podcast focused on helping professionals become more effective managers and leaders. Each week, we discuss specific actions for professionals to take to achieve their desired management and career objectives. Manager Tools won Best Business Podcast Award in 2006, 2007, 2008, and 2012 as well as the People's Choice ...
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Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
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Medical Device News – january 2024 Regulatory Update
Manage episode 394372815 series 2591977
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
Medboard
Who is Medboard
- Medboard: https://www.medboard.com/
EU
EU Reference laboratories EURL
- EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713
Letter to EU Parliament
Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT
MDCG 2023-7 on Clinical Investigation
- MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf
MDCG 2019-07 rev 1 on PRRC
- MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf
MDCG 2021-27 on Importer and Distributor
MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf
MDCG 2023-5 on Annex XVI class
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf
MDCG 2023-6 on Annex XVI Equivalency
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf
Companion Diagnostics CDx
EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf
Switzerland
Guidance on Devices with no medical purpose
- Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
Emergency use of non-conform device
- Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf
Notified Bodies:
New Notified Body under EU MDR
43rd NB MDR – CESKY METROLOGICKY INSTITUT – Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true
Notified Body Situation
- Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf
Training:
EU MDR training
- Green Belt training
- 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/
- 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/
- 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/
Medical Device e-Training
- eTraining
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
ROW
- Mexico:
- Mexico registration rules
Guide for obtaining the Health Registry of Medical Devices – https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/
- Brazil:
- Brazil is calling Innovative Medical Devices
- Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto
- Hong-Kong:
- Hong-Kong Guidances
- Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf
- Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf
- Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
- Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf
- Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf
- USA:
- USA Export documents transition to digital
- Transition to Electronic Export Documents – Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry
- India:
- India New platform to register
- National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=
- Australia:
Australia Boundary and Combination products
guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf
- Australia on Custom-Made and Patient Match
- How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
- Malaysia
- Malaysia is telling rules on Borderline products
- Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc
- Malaysia is telling rules for classification of products
- List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso
Podcast Nostalgia
Podcast Nostalgia
- Episode 262 – What is usability: https://podcast.easymedicaldevice.com/262-2/
- Episode 263 – Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/
- Episode 264 – Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/
- Episode 265 – Heatmap: https://podcast.easymedicaldevice.com/265-2/
The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
Del
Manage episode 394372815 series 2591977
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
Medboard
Who is Medboard
- Medboard: https://www.medboard.com/
EU
EU Reference laboratories EURL
- EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713
Letter to EU Parliament
Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT
MDCG 2023-7 on Clinical Investigation
- MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf
MDCG 2019-07 rev 1 on PRRC
- MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf
MDCG 2021-27 on Importer and Distributor
MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf
MDCG 2023-5 on Annex XVI class
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf
MDCG 2023-6 on Annex XVI Equivalency
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf
Companion Diagnostics CDx
EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf
Switzerland
Guidance on Devices with no medical purpose
- Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
Emergency use of non-conform device
- Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf
Notified Bodies:
New Notified Body under EU MDR
43rd NB MDR – CESKY METROLOGICKY INSTITUT – Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true
Notified Body Situation
- Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf
Training:
EU MDR training
- Green Belt training
- 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/
- 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/
- 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/
Medical Device e-Training
- eTraining
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
ROW
- Mexico:
- Mexico registration rules
Guide for obtaining the Health Registry of Medical Devices – https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/
- Brazil:
- Brazil is calling Innovative Medical Devices
- Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto
- Hong-Kong:
- Hong-Kong Guidances
- Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf
- Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf
- Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
- Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf
- Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf
- USA:
- USA Export documents transition to digital
- Transition to Electronic Export Documents – Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry
- India:
- India New platform to register
- National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=
- Australia:
Australia Boundary and Combination products
guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf
- Australia on Custom-Made and Patient Match
- How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
- Malaysia
- Malaysia is telling rules on Borderline products
- Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc
- Malaysia is telling rules for classification of products
- List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso
Podcast Nostalgia
Podcast Nostalgia
- Episode 262 – What is usability: https://podcast.easymedicaldevice.com/262-2/
- Episode 263 – Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/
- Episode 264 – Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/
- Episode 265 – Heatmap: https://podcast.easymedicaldevice.com/265-2/
The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
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Lik Medical Device made Easy Podcast
The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
…
continue reading
How do I start an online business? How do I build a brand online? How do I get traffic and attention to my online business? The biggest question is, can I start a business online and replace my current JOB? Welcome to The Rock Your Brand podcast show where we answer ALL of these questions and a ton MORE! Scott Voelker, the host will share with you everything you need to know and help you to build a Future Proof Business that will allow you the ultimate Freedom. Scott shares tips and strategi ...
…
continue reading
Kipp Bodnar (HubSpot’s CMO) and Kieran Flanagan (Zapier’s CMO), lead you down the rabbit hole of marketing trends, growth tactics and innovation. On the way you’ll pick up undiscovered strategies to give you that slight edge for success. These are not your typical twitter thread regurgitated marketing tactics that everyone is doing. These are new methods, with unfiltered examination of successful fresh ideas.
…
continue reading
Radio Advisory is your weekly download on how to untangle healthcare's most pressing challenges, powered by 40 years of Advisory Board research. Whether it's workforce shortages, industry disruptors, or health equity strategy, we're here to help. Our hosts and seasoned researchers talk with industry experts to equip you with knowledge to confront today’s unanswered questions in healthcare. New episodes drop every Tuesday. | www.advisory.com
…
continue reading
1
The Brutal Truth about Sales and Selling - We interview the world's best B2B Enterprise salespeople.
Brian Burns
No BS Allowed - Are you sick of empty suits telling you to work harder? - Learn about The Maverick Selling Method, which models the world's best salespeople and what they do differently. If you are in sales and are passionate about selling, you will like this podcast. The focus is on b2b sales and selling. If you are selling or in sales, this podcast is for you. I cover cold calling, spin selling, challenger sale, solution selling, and advanced selling skills. Strategic selling, LinkedIn, sa ...
…
continue reading
Welcome to an exciting new season of the podcast Your Career: Choice or Chance? - as we dive into the ever-evolving world of GenAI in the Workplace and explore the latest trends, experiences, and career journeys shaping the future of work as AI is increasingly ingrained in it. Each episode provides fresh insights, addressing the transformative influence of GenAI in shaping the workforce of tomorrow, making it a must-listen for anyone interested in staying ahead in the ever-evolving world of ...
…
continue reading
The American healthcare system is one of the most innovative in the world. But it’s also riddled with complex challenges, such as access to affordable medications, inefficiency and administrative burdens, and communication barriers between providers. There’s clearly a better way—and at Surescripts, we have a unique sightline into what that may be. In this series, host Melanie Marcus, Chief Marketing Officer of Surescripts, sits down with today’s most inspiring and innovative leaders in healt ...
…
continue reading
Tired of management theory? Want to learn specific skills to help improve your management performance? Then Manager Tools is the podcast for you! Manager Tools is a weekly business podcast focused on helping professionals become more effective managers and leaders. Each week, we discuss specific actions for professionals to take to achieve their desired management and career objectives. Manager Tools won Best Business Podcast Award in 2006, 2007, 2008, and 2012 as well as the People's Choice ...
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continue reading
Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
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continue reading
Business tips for startups by proven entrepreneurs
…
continue reading
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