Easy Medical Device Podcast

Episode 23 – CRO selection with Alethea Wieland

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project. This is critical to be able to get the right result and avoid losing money. There are so many elements to look at that Alethea will really go in detail on each aspect and provide good examples. So before to start the selection of your Clinical Research Organization, you need to listen to that. And if you want to get a pdf summary of the TOP 10 criteria to select a CRO that Alethea co-authored with Concetta Dudley, then look the link at the bottom.

If you like this show, please don’t forget to subscribe so you are notified when a new episode is released and if you can also provide me with a review, this would make my day.

• iTunes Podcast: https://itunes.apple.com/fr/podcast/medical-device-made-easy-podcast/id1447060380
• Spotify: https://www.spotify.com/
• Stitcher: https://www.stitcher.com/s?fid=343133&refid=stpr
• TuneIn: http://tun.in/pjgym
• Google Podcast: https://www.google.com/podcasts?feed=aHR0cDovL2ZlZWRzLmZlZWRidXJuZXIuY29tL01lZGljYWxEZXZpY2VNYWRlRWFzeVBvZGNhc3Q%3D

Who is Alethea Wieland

Alethea Wieland is Founder and President of Clinical Research Strategies, LLC, an executive-level management consulting firm and contract research organization for the life science industry established in 2011.

Her focus is on offering agile, flexible staffing models for clinical trial resourcing; training and managing resilient, high-performing clinical operations teams using human-centered design techniques; and, mitigating risks of clinical trials by facilitating the best Sponsor-CRO partnerships who practice accountability, compliance, and transparency.

She is an advocate of strong contractual arrangements, and frequently meeting with regulators and numerous stakeholders which results in a win-win mindset. Learn more by connecting with her on LinkedIn, and by visiting her website at www.clinicalresearchstrategies.com.

Links

• Clinical Research Strategies: https://www.clinicalresearchstrategies.com
• Alethea Wieland Linkedin: https://www.linkedin.com/in/alethea
• Alethea Wieland Twitter: https://twitter.com/alethea_wieland
• Episode 22: Clinical Trials with Alethea Wieland: https://podcast.easymedicaldevice.com/22
• TOP 10 Criteria to select a CRO: https://podcast.easymedicaldevice.com/wp-content/uploads/2019/05/Sponsors-Top-10-Checklist-for-Selecting-a-CRO-31Mar2019.pdf

https://www.youtube.com/embed/d63hDHyRaAk?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project. The post Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland appeared first on Medical Device made Easy Podcast.

Episode 22 – How to perform a Clincial Trial with Alethea WielandPodcast Episode 22 – How to perform a Clinical Trial with Alethea Wieland

Webpage: https://podcast.easymedicaldevice.com/22

What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation?

I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials.

This episode is really a masterclass for people that are not clear about Medical Device requirements for Clinical Trials or Investigation. We will talk about Europe but also the USA, and some other countries in the World. On the show notes, I also included some of the references that Alethea is mentioning as Standards, regulations or books to read.

This is the first part of 2 episodes. The second episode will be about “How to select a CRO?” So don’t miss it.

If you like this show, please don’t forget to subscribe so you are notified when a new episode is released and if you can also provide me with a review, this would make my day.

• iTunes Podcast: https://itunes.apple.com/fr/podcast/medical-device-made-easy-podcast/id1447060380
• Spotify: https://www.spotify.com/
• Stitcher: https://www.stitcher.com/s?fid=343133&refid=stpr
• TuneIn: http://tun.in/pjgym
• Google Podcast: https://www.google.com/podcasts?feed=aHR0cDovL2ZlZWRzLmZlZWRidXJuZXIuY29tL01lZGljYWxEZXZpY2VNYWRlRWFzeVBvZGNhc3Q%3D

Who is Alethea Wieland

Alethea Wieland is Founder and President of Clinical Research Strategies, LLC, an executive-level management consulting firm and contract research organization for the life science industry established in 2011.

Her focus is on offering agile, flexible staffing models for clinical trial resourcing; training and managing resilient, high-performing clinical operations teams using human-centered design techniques; and, mitigating risks of clinical trials by facilitating the best Sponsor-CRO partnerships who practice accountability, compliance, and transparency.

She is an advocate of strong contractual arrangements, and frequently meeting with regulators and numerous stakeholders which results in a win-win mindset. Learn more by connecting with her on LinkedIn, and by visiting her website at www.clinicalresearchstrategies.com.

Links

► Clinical Research Strategies: https://www.clinicalresearchstrategies.com
► Alethea Wieland Linkedin: https://www.linkedin.com/in/alethea
► Alethea Wieland Twitter: https://twitter.com/alethea_wieland
► ISO 14155: http://tidd.ly/35fb9ead
► Meddev 2.7/4: https://ec.europa.eu/docsroom/documents/10336/attachments/1/translations/en/renditions/native
► ICH Good Clinical Practice: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
► Book: Rigor Mortis – Richard Harris: https://amzn.to/2ZXlphG

Don’t forget to subscribe to the Youtube Channel to be notified when I release another video.

https://www.youtube.com/embed/fiH3AxZUk-I?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 22 – Clinical Trial with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation? I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials. The post Episode 22 – Clinical Trial with Alethea Wieland appeared first on Medical Device made Easy Podcast.

Episode 21 – How to Master Regulatory Affairs with Samantha Alsbury

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to have an experience they should start somewhere. So how to do that?

Samantha Alsbury from TOPRA (The Organization for Professionals in Regulatory Affairs) will share with us her thoughts on this.

• How long to be ready to work in Regulatory affairs?
• What are the important skills to have to be a good professional?
• Is the transition from one regulatory field to another difficult to do?

She will really provide us all her knowledge on this and also give us some information about TOPRA. This organization can help you to perform this transition and also to improve on your Regulatory Affairs career.

On Sept 30th to October 2nd, 2019 TOPRA is also organizing an event in Dublin where you can network with professionals. This can also be good for your career.

Samantha Alsbury Bio

Samantha Alsbury completed her Ph.D. in Molecular Genetics at UCL in 2004, continuing with scientific research she moved into neurobiology using genetics as a tool at King’s College London before taking up a post as Senior Lecturer in Biomedical Science at the University of Greenwich. After taking on the role of Programme leader for a distance learning MSc in Biomedical Science for professional Biomedical Scientists Samantha joined The Organisation for Professionals in Regulatory Affairs (TOPRA) as the Head of Professional Development in 2016. In this role, she oversees the training, accreditation, qualifications and continuing professional development policy.

Useful Links

• Samantha Linkedin: https://www.linkedin.com/in/samantha-cooper-n%C3%A9e-alsbury-76157834/
• TOPRA website: http://www.topra.org/
• Twitter:
  https://twitter.com/SamanthaAlsbury
• Facebook Page:
  https://www.facebook.com/topra.org/
• Linkedin Group: https://www.linkedin.com/groups/1182787

https://www.youtube.com/embed/XigouOhS2TQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Youtube Video: Episode 21 – How to master Regulatory Affairs with Samantha Alsbury from TOPRA

The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere. So how to do that? Samantha Alsbury from TOPRA will help us on this new episode. The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made Easy Podcast.

Episode 20 – Blockchain Healthcare with Khuram Malik

Blockchain is really a trending word that we start to hear on all social media. It’s apparently a revolution and to help the EasyMed Nation I decided to find someone to help us understand it. What is Blockchain?

Khuram Malik from Stratagem.io will be my guest this week and will try to explain to us this difficult topic. Blockchain can also be applied to the Healthcare Industry but how? Will this be a revolution for Medical Device products?

Who is Khuram Malik?

Khuram is Chief Strategist and Founder of Stratagem.io. Between 2013 and 2015 he has worked with over 150 Founders and Business Leaders around the globe helping them raise investment, improve their sales and marketing, hire great talent and develop amazing customer experiences.

Khuram loves game-changing start-ups,  pretty data visuals, and good writing.

He is also the author of Billion Dollar Muslim; a calling to people of his community to embrace and adopt entrepreneurship wholesale.

Links

• Khuram Malik Linkedin:
  https://www.linkedin.com/in/khurammalik/
• Stratagem.io: http://stratagem.io/
• Khuram Malik book Billion Dollar Muslim:
  Billiondollarmuslim.com
• Essential Drucker – Peter Drucker: https://amzn.to/2ZiLeZf
• Elif Shafak TedX:
  https://www.ted.com/talks/elif_shafak_the_revolutionary_power_of_diverse_thought?language=en
• The Forty Rules of Love – Elif Shafak: https://amzn.to/2Dor8TN

https://www.youtube.com/embed/XXe-G7Tw39o?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Youtube Video : Blockchain for Healthcare with Khuram Malik

The post Episode 20 – What is a Blockchain with Khuram Malik appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Blockchain for Healthcare is a new Technology. On this episode, Khuram Malik will tell us what is Blockchain and how Medical Devices can use it. The post Episode 20 – What is a Blockchain with Khuram Malik appeared first on Medical Device made Easy Podcast.

Episode 19 – Rule 11 Software Devices with Cyrille Michaud MD101 ConsultingAudio Episode 19 – Rule 11 Software Devices with Cyrille Michaud

With the evolution of software in the Medical Device industry, the legislation is also changing. With the MDD 93/42/EC software was not really a big topic, but today with Artificial Intelligence, Virtual Reality, Image recognition, Blockchain… it is important to consider it.

So the MDR 2017/745 created the classification rule 11 to provide some changes. Cyrille Michaud from MD101 Consulting is a software developer who works on the Quality and Regulatory field with his customers. He will help us to have a better understanding of this rule and how manufacturers should work with it.

About Cyrille Michaud

Based in France, Cyrille Michaud is managing partner as MD101 Consulting. He is an information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was project director in a medical imaging start-up. His main achievements were the ISO 13485 certification and the CE Mark and FDA clearances. The value he brings: solving technical and regulatory issues, building business plans and regulatory strategies for manufacturers of software medical devices.

Links

• MD101 Consulting website: www.md101consulting.com
• MD101 Consulting Linkedin Page:
  https://www.linkedin.com/company/md101-consulting/
• Cyrille Michaud Linkedin:
  https://www.linkedin.com/in/cyrillemichaud/
• Blog Cyrille Michaud: http://blog.cm-dm.com/
• Rendez-Vous Expert Medtech: https://expertsmedtech.com/
• Episode 15 – MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/15

https://www.youtube.com/embed/XFW-3481j2k?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the industry. Let's clarify that with Cyrille. The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast.