62 episodes

Welcome to the Combinate Podcast, a show that brings you closer to what makes MedTech and BioTech incredible, the people behind the scenes.

I’ve worked on product development teams in the Medical Device and Pharmaceutical industries for the last decade of my life and my aim with this podcast is to understand.

Each week, I sit down with leaders to examine the roadblocks in development and access we face and bring to light concepts and tools from our industry and others that will help address those.

I hope you'll join me.

Combinate Podcast - Quality in Pharma and Medical Devices Subhi Saadeh

    • Science
    • 5.0 • 4 Ratings

Welcome to the Combinate Podcast, a show that brings you closer to what makes MedTech and BioTech incredible, the people behind the scenes.

I’ve worked on product development teams in the Medical Device and Pharmaceutical industries for the last decade of my life and my aim with this podcast is to understand.

Each week, I sit down with leaders to examine the roadblocks in development and access we face and bring to light concepts and tools from our industry and others that will help address those.

I hope you'll join me.

    060 - "Trusted Advisory" with Elena Kyria

    060 - "Trusted Advisory" with Elena Kyria

    Elena Kyria, CEO of Elemed joins the podcast and discusses:

    - Why People stay in roles and why they leave
    -Starting Elemed
    -The trusted advisory role that recruiters play
    -Community work on EU MDR and RAPS

    Elena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements across Europe. Elena runs one of the largest linkedin groups focused on EU MDR and is the Head of Communications/Marketing for the Switzerland chapter of RAPS.

    • 42 min
    059 - "Literature Review" with Ethan Drower

    059 - "Literature Review" with Ethan Drower

    On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust.

    Ethan and I discuss:

    - A problem-driven career

    - Challenges with EU MDR Clinical Evaluation Reports(CER's)

    - Literature Search and Literature Review

    Ethan Drower is the Co-Founder and Operating Partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies’ Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. CiteMed’s top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with the European Commission regulations. 

    • 41 min
    058 - "PMSR Globally" with Khaudeja Bano

    058 - "PMSR Globally" with Khaudeja Bano

    On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss:

    - PMSR and Risk Management 

    - Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies.

    - PMSR Regulatory Landscape Globally (Outside of the US)

    Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

    • 44 min
    057 - "At Least, Try" with Rizwan Chaudhrey

    057 - "At Least, Try" with Rizwan Chaudhrey

    On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss:

    Launching Chats with Chaudhrey during the Pandemic
    Conferences and Expos
    How to use LinkedIn to build your personal brand
    Getting Started

    Rizwan is a blogger on Life Science/ Pharma Bio-Pharma from Drug Discovery to Drug Delivery and all things in between. He aims to connect and Inform those working across the whole value chain, through news, video interviews, podcasts and content.

    Rizwan's  Podcast Series: #ChatsWithChaudhrey The Podcast can be found on his YouTube Channel: RSK Life Science Media
    https://youtube.com/channel/UC9vdET2xLlGweqveW6JmQdQ

    • 46 min
    056 - "Non-Promotional Compliance" with Darshan Kulkarni

    056 - "Non-Promotional Compliance" with Darshan Kulkarni

    On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University.

    Darshan and I discuss:

    - Non-Promotional Speech and Scientific Discussion

    - Medical Affairs vs. Sales and interaction with HCP's

    - Free Speech in Tech and what it might mean for Pharma

    Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.

    • 33 min
    055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

    055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

    On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss:
    - Critical Tasks: What the guidance says , how to select them and what it means for HF study design
    - Knowledge Tasks: Meeting regulatory expectations and evaluation the IFU
    - Usability, HF Studies and Residual Risk
    Prior to joining Sanofi as Usability Leader, Alexandra Benbadis was a Senior Human Factors Consultant at Emergo by UL. She's a two-time Tufts alumna and has taught two courses through the Tufts Experimental College focused on the design of public spaces and inclusive design.

    • 50 min

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