Podcasts Business Let's talk pharmaceutical, global medical devices + IVD regulatory services

Let's talk pharmaceutical, global medical devices + IVD regulatory services

25 episodes

None

Podcasts

Sponsorship in Australia and New Zealand - What devices manufacturers and local representatives need to know.

Published: March 16, 2021, 9:59 p.m.
Duration: 37 minutes 8 seconds

Listed in: Business

FDA Guidances in 2020: A high-level pharma, device and diagnostic overview

Published: Feb. 16, 2021, 10:33 p.m.
Duration: 44 minutes 9 seconds

Listed in: Business

RAPS Webcast recording: Global Medical Device and IVD Regulatory Changes in 2020 and Their Impact to Asia Pacific

Published: Jan. 20, 2021, 1:06 a.m.
Duration: 1 hour 15 minutes 4 seconds

Listed in: Business

Our top 10 FAQs answered for 2020

Published: Nov. 18, 2020, 3:12 a.m.
Duration: 43 minutes 41 seconds

Listed in: Business

Hitting the Accelerator! TGA's Approaches to Speeding Up Medicine Approvals

Published: Oct. 20, 2020, 9:37 p.m.
Duration: 22 minutes 28 seconds

Listed in: Business

Medical Device Regulations Under COVID - What You Need To Know

Published: Sept. 22, 2020, 6:21 a.m.
Duration: 45 minutes 43 seconds

Listed in: Business

Blood, Sweat and Tears: An Update to In Vitro Diagnostics Regulatory Requirements Worldwide

Published: Aug. 18, 2020, 11:27 p.m.
Duration: 39 minutes 25 seconds

Listed in: Business

Medical Device Software: Current Developments in the Regulatory World

Published: July 14, 2020, 10:42 p.m.
Duration: 38 minutes 39 seconds

Listed in: Business

Let's talk clinical evidence reports - what you need to know.

Published: June 16, 2020, 11:40 p.m.
Duration: 28 minutes 48 seconds

Listed in: Business

Faster Australian Medicine Approvals through Leveraging International Evaluations

Published: May 20, 2020, 12:03 a.m.
Duration: 20 minutes 26 seconds

Listed in: Business

Emergency approvals - moving things along in a Pandemic

Published: April 9, 2020, 4:07 a.m.
Duration: 39 minutes 53 seconds

Listed in: Business

Biocompatibility - Chemistry takes over from biology and cell cultures replace laboratory animals

Published: March 18, 2020, 4:14 a.m.
Duration: 29 minutes 22 seconds

Listed in: Business

Nobody Complained! Post market reporting under MDR.

Published: Feb. 19, 2020, 1:32 a.m.
Duration: 21 minutes 38 seconds

Listed in: Business

Harmonization - the Triumphs and the Tragedies

Published: Jan. 22, 2020, 5:53 a.m.
Duration: 30 minutes 20 seconds

Listed in: Business

The Case For Quality

Published: Nov. 21, 2019, 1 a.m.
Duration: 53 minutes 35 seconds

Listed in: Business

Shouldn't diagnostics be different to Medical Devices? Understanding the changes to diagnostics in Europe with the IVDR.

Published: Oct. 24, 2019, 12:45 a.m.
Duration: 1 hour 1 minute 54 seconds

Listed in: Business

When Software becomes a Medical Device (SaMD)

Published: Sept. 27, 2019, 1:30 a.m.
Duration: 57 minutes 10 seconds

Listed in: Business

Time to get serious on postmarket

Published: June 20, 2019, 1:02 a.m.
Duration: 57 minutes 38 seconds

Listed in: Business

Documentation Deconstructed: Understanding the Technical file

Published: May 22, 2019, 2:10 a.m.
Duration: 58 minutes 33 seconds

Listed in: Business

How to survive the Perfect Storm - International Harmonization and Lessons from Brexit and the MDR

Published: April 24, 2019, 1:45 a.m.
Duration: 57 minutes 20 seconds

Listed in: Business

A Bulletproof Clinical Evaluation Report: Making them stand up to regulatory scrutiny

Published: March 21, 2019, 5:50 a.m.
Duration: 58 minutes 11 seconds

Listed in: Business

Biocompatibility Challenges for 2019

Published: Feb. 22, 2019, 2:18 a.m.
Duration: 51 minutes 2 seconds

Listed in: Business

Making American Guidance Understandable Again: How FDA's new enthusiasm for harmonization brings opportunity for international firms.

Published: Jan. 29, 2019, 4:25 a.m.
Duration: 1 hour 6 minutes 52 seconds

Listed in: Business

FDA and ISO stars aligning on ISO 10993

Published: Dec. 16, 2018, 11:15 p.m.
Duration: 57 minutes 28 seconds

Listed in: Business

Taking a 510(k) Down Under...leveraging US (and Canadian and Japanese) approvals for TGA registration

Published: Dec. 13, 2018, 4:27 a.m.
Duration: 45 minutes 46 seconds

Listed in: Business