Freyr Regulatory Radio

Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU

In the last episode of Freyr Regulatory Radio, Season 4, our experts discuss key considerations for Comparative Quality Studies for a proposed biosimilar product in the EU.
Furthermore, this episode throws light upon the criteria for the reference biological products and its evaluation.
To know more about Season 4, visit: https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products 

Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars

Streamlined biologic product development involves proper Regulatory assessment and overcoming challenges encountered during the CMC development phase. This episode will discuss the challenges faced during complex biological product development.
Furthermore, our experts will express their Regulatory views on variability in batch-to-batch testing, impurities testing, viral load clearance, and factors encountered in the biological product arena.
To know more about the Season 4, visit: https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products 

Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars

Biological product development involves proper planning and experimentation. Comprehending the biological CMC requirements is one such critical aspect during its development. This episode will detail the specifications required during biologics/biosimilar development.
Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details. 

Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars

Episode 2 will detail the various guidelines for biological product development and approval in the market. The reference guidelines discussed in the podcast will include the following:
Guidelines that describe the expression construct, cloning, cell bank preparation, and characterization of biological products.
Guidelines to be referred for biologics drug substance development and manufacturing.
Guidelines to be referred for viral safety evaluation and analytical method validation of the products.
Stability management of biological products.
 
Our Regulatory experts will share more details about the subsidiary guidelines to be referred by a pharma company for streamlining Biologics development.

Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU

Introduction to Biologics and Biosimilars is the core of this episode. Our Regulatory experts will give an overview of the different Regulatory approval pathways for Biologics and Biosimilars in the EU. Additionally, they will discuss the significance and requirements of Regulatory submissions and scientific advice during the Regulatory processes.
To know more about the Season 4: EU Regulatory Pathways for Biological Products, visit: https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products 

Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products

The Regulatory Affairs Life Cycle Management of a drug is considerably different from other commodities. The Office of the Lifecycle of Drug Products, a department under the Office of Pharmaceutical Quality (OPQ) under CDER, oversees the responsibility of delivering quality medicines to the population. Our experts elaborate on the subdivisions and their responsibilities toward the safety and efficacy of medications.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry  

Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting

Patents are non-tangible assets for an organization/individual. To safeguard the innovator’s rights, the US FDA follows a unique patenting pathway for innovations. The United States Patent and Trademark Office (USPTO) looks after the awarding and verification of Intellectual Proprietary Rights. Our experts enlist various exclusivity periods stated under different designations and more.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance

Expedited drug development pathways ensure the availability of treatment at the earliest. The US FDA’s facilitated Regulatory pathways give priority to innovators based on the nature of their innovation and more. Our experts discuss (i) Fastrack, (ii) Breakthrough Therapy, (iii) Accelerated Approval, and (iv) Priority Review and their impact on drug development timelines.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

Season 3: Episode 3 - Procedures for Medicinal Products’ Approval

Understanding the unique benefits of standard drug approval pathways by the US FDA. Our experts talk about the importance of the different stages of drug development, right from the drug discovery/conceptual phase, pre-clinical phase, and clinical phase to the FDA review.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

Season 3: Episode 2 - GDUFA & PDUFA Guidelines

Establishment of the GDUFA and PDUFA guidelines and their impact on innovators and generics. Our experts discuss various merits of the guidelines and the significant changes signed into the law with each latest amendment.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry