Freyr Regulatory Radio
By Freyr Solutions
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Category: Medicine
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Subscribers: 1
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Episodes: 29
Description
Freyr is a leading, niche, full-service global Regulatory Solutions, and Services Company supporting, Large, Medium, and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Food and Food Supplements | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.
| Episode | Date |
|---|---|
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Season 5: Episode 5 – Reporting Adverse Events Under MoCRA
|
Mar 01, 2024 |
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Season 5: Episode 4 – Safety in Focus – MoCRA Safety Substantiation
|
Mar 01, 2024 |
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Season 5: Episode 3 – Mastering Product Listing: A Comprehensive Guide to MoCRA Requirements
|
Mar 01, 2024 |
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Season 5: Episode 2 – Untangling the Responsibilities of MoCRA Agents and RPs
|
Mar 01, 2024 |
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Season 5: Episode 1 – MoCRA Facility Registration: What You Need to Know?
|
Mar 01, 2024 |
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Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU
|
Sep 26, 2023 |
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Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars
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Sep 19, 2023 |
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Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars
|
Sep 12, 2023 |
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Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars
|
Sep 05, 2023 |
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Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU
|
Aug 29, 2023 |
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Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products
|
Feb 28, 2023 |
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Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting
|
Feb 21, 2023 |
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Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
|
Feb 14, 2023 |
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Season 3: Episode 3 - Procedures for Medicinal Products’ Approval
|
Feb 07, 2023 |
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Season 3: Episode 2 - GDUFA & PDUFA Guidelines
|
Jan 31, 2023 |
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Season 3: Episode 1 - US Market Entry & Landscape In Regulatory Affairs
|
Jan 24, 2023 |
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Season 2: Episode 6 - Pharma Advertising and Promotions: Canada
|
Dec 14, 2022 |
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Season 2: Episode 5 - Pharma Advertising and Promotions: Mexico
|
Dec 07, 2022 |
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Season 2: Episode 4 - Pharma Advertising and Promotions: United Kingdom
|
Nov 30, 2022 |
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Season 2: Episode 3 - Pharma Advertising and Promotions: Lithuania
|
Nov 23, 2022 |
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Season 2: Episode 2 - Pharma Advertising and Promotions: Australia
|
Nov 16, 2022 |
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Season 2: Episode 1 - Pharma Advertising and Promotions: Zimbabwe
|
Nov 09, 2022 |
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Season 2: Episode 0 - Pharma Advertising and Promotions: Introduction
|
Oct 26, 2022 |
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Episode 6. Regulatory Compliance - The Future & Next Steps
|
May 12, 2022 |
|
Episode 5. Global & the European Facilitated Regulatory Pathways
|
May 02, 2022 |
|
Episode 4. Monitoring Medicines and Supervisory Committees
|
Apr 22, 2022 |
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Episode 3. Medicinal Products Lifecycle & Regulatory Pathways
|
Apr 13, 2022 |
|
Episode 2. Centralised and Decentralised Procedures
|
Apr 04, 2022 |
|
Episode 1. The European Medicines Regulatory Network
|
Mar 25, 2022 |