Podcast

December 14, 2022

063 – Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: Key Topics Challenges with

December 7, 2022

062 – Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy. Stefan discusses: Discounts, Rebates,

November 30, 2022

061 – Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling

On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc. Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust

November 23, 2022

060 – Why People Leave, Starting Elemed and 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

November 16, 2022

059 – Literature Review, EU MDR CER’s, and Being Problem Driven 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

November 9, 2022

058 – PMSR Globally, Different Clinical Roles and Risk Management 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: Key Topics PMSR and

November 2, 2022

057 – Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey

On this episode, I was joined by Rizwan Chadhrey, of RSK Life Sciences Media. Rizwan and I discuss:Launching Chats with Chaudhrey during the PandemicConferences and ExposHow to use LinkedIn to

October 26, 2022

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: Key

October 19, 2022

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: Key Topics Critical Tasks: What the guidance says , how to select them

October 12, 2022

054 – “EUDAMED” with Richard Houlihan

On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss: Key Topics History of Eudamed (Starting with EU Legislation in 2010) The 6 modules

October 5, 2022

053 – “Duct Tape and Bubble Gum” with Chris Tsai

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Chris Tsai is the Director of Implementation at Boothroyd Dewhurst Inc. Chris is

September 28, 2022

052 – “All Work is Process” with Larry Mager

On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more

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