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Podcast Episode's:
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Season 5: Episode 5 – Reporting Adverse Events Under MoCRA
<p>MoCRA brings significant changes to the way adverse events associated with cosmetic products are reported in the US. This episode delves into the nitty-gritty of MoCRA's adverse event reporting requirements, helping you understand your responsibilities and ensuring you stay compliant.</p>
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Season 5: Episode 4 – Safety in Focus – MoCRA Safety Substantiation
<p>MoCRA raises the bar for cosmetic safety and demonstrating "adequate substantiation" is key. But what exactly does that mean? This episode unlocks the secrets of MoCRA safety substantiation, guiding you through the process with expert insights. It also empowers you to understand and implement MoCRA safety requirements and MoCRA safety substantiation.</p>
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Season 5: Episode 3 – Mastering Product Listing: A Comprehensive Guide to MoCRA Requirements
<p>In today's episode, we're embarking on a deep dive into MoCRA's product listing requirements. We'll unravel what this entails, who exactly needs to adhere to it, and the crucial information that must be included. Whether you're a seasoned industry professional or just stepping into the Regulatory arena, this episode is a must-listen for anyone seeking clarity on MoCRA's product listing mandates.</p>
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Season 5: Episode 2 – Untangling the Responsibilities of MoCRA Agents and RPs
<p>This episode untangles the role of the Responsible Person (RP) and the US Agent. We'll break down their key differences and responsibilities, ensuring you stay compliant and navigate the market smoothly. Whether you're a manufacturer, distributor, or simply curious about the industry, this episode is your essential guide to understanding MoCRA's key players. Tune in and gain clarity on MoCRA's RP and US Agent.</p>
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Season 5: Episode 1 – MoCRA Facility Registration: What You Need to Know?
<p>Understanding MoCRA's Facility Registration requirements is crucial for cosmetic manufacturers. It ensures transparency and product safety, paving the way for smooth operations in the US market. Compliance with MoCRA's facility registration requirements fosters trust and builds a strong foundation for your cosmetic brand's success in the US.</p>
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Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU
<p>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.</p>
<p>Furthermore, this episode throws light upon the criteria for the reference biological products and its evaluation.</p>
<p>To know more about Season 4, visit: <a href='https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products'>https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products</a> </p>
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Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars
<p>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.</p>
<p>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.</p>
<p>To know more about the Season 4, visit: <a href='https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products'>https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products</a> </p>
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Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars
<p>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.</p>
<p>Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details. </p>
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Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars
<p>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:</p>
<ul><li>Guidelines that describe the expression construct, cloning, cell bank preparation, and characterization of biological products.</li>
<li>Guidelines to be referred for biologics drug substance development and manufacturing.</li>
<li>Guidelines to be referred for viral safety evaluation and analytical method validation of the products.</li>
<li>Stability management of biological products.</li>
</ul>
<p> </p>
<p>Our Regulatory experts will share more details about the subsidiary guidelines to be referred by a pharma company for streamlining Biologics development.</p>
Listen:
Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU
<p>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.</p>
<p>To know more about the Season 4: EU Regulatory Pathways for Biological Products, visit: <a href='https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products'>https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products</a> </p>
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Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products
<p>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.</p>
<p>To know more about Season 3, visit <a href='https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry'>https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry </a> </p>
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Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting
<p>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.</p>
<p>To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry </p>
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Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
<p>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.</p>
<p>To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry </p>
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Season 3: Episode 3 - Procedures for Medicinal Products’ Approval
<p>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.</p>
<p>To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry </p>
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Season 3: Episode 2 - GDUFA & PDUFA Guidelines
<p>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.</p>
<p>To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry </p>
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Season 3: Episode 1 - US Market Entry & Landscape In Regulatory Affairs
<p>Introduction to the USFDA framework and the cascade of events ultimately lead to authorization to market a drug product. Our experts elaborate on every department under the US FDA, focusing on the CBER and the CDER.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry </p>
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Season 2: Episode 6 - Pharma Advertising and Promotions: Canada
<p>The pharmaceutical advertising in Canada for prescription drugs has always been under scrutiny as laws governing Direct-to-Consumer (DTC) advertisements of prescription-only medicines are misunderstood by organizations. The governing authority for medicines, Health Canada, is responsible for general advertisement and promotions. Our host highlights the laws and regulations laid down by Health Canada. </p>
<p>Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions</p>
<p> </p>
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Season 2: Episode 5 - Pharma Advertising and Promotions: Mexico
<p>The Mexican pharmaceutical promotional regulations for advertising drugs, governed by the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), are subjected to specific requirements to protect Healthcare Professionals (HCPs) and consumers from any associated risks. In this episode, our host describes the general requirements of drugs from an advertising perspective, legislated and issued by the Code of Conduct. </p>
<p>Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions</p>
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Season 2: Episode 4 - Pharma Advertising and Promotions: United Kingdom
<p>Post-Brexit, the United Kingdom’s advertising review team scrutinizes published advertising in selected media, and we investigate referrals from colleagues in the Agency or other Regulatory Authorities. Our host addresses the necessary pharmaceutical advertising regulations a pharmaceutical organization must follow to ensure that the advertising material is thoroughly reviewed before the issue, thus avoiding misleading messages and protecting consumers from any potential negative impact.</p>
<p>Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions</p>
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Season 2: Episode 3 - Pharma Advertising and Promotions: Lithuania
<p>The Republic of Lithuania reflects good economic fortune for medicine manufacturers’ regional investments. To explore the Lithuanian market, manufacturers must obtain approvals from the State Medicines Control Agency. Our host gives us an insight into the Regulatory framework involved in the successful advertising and promotion of medicines.</p>
<p>Tune into other episodes of Season 2: <a href='https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions'>https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions</a></p>
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Season 2: Episode 2 - Pharma Advertising and Promotions: Australia
<p>Pharmaceutical advertisement in Australia is self-regulated or co-regulated, with various bodies having their codes relevant to the promotion of drugs. Our host gives a fair understanding of how the Regulatory environment can present a challenge for companies bringing new products to the market and promoting them.</p>
<p>Tune into other episodes of Season 2: <a href='https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions'>https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions</a></p>
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Season 2: Episode 1 - Pharma Advertising and Promotions: Zimbabwe
<p>A considerable grey area exists between providing information and promoting medicines in a semi-regulated market like Zimbabwe. Our host explores the pharmaceutical laws and regulations laid down by the Medicines Control Agency of Zimbabwe and elaborates on the key takeaways from the advertising legislative framework.</p>
<p>Tune into other episodes of Season 2: <a href='https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions'>https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions</a></p>
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Season 2: Episode 0 - Pharma Advertising and Promotions: Introduction
<p>Welcome to Regulatory Radio, brought to you by Freyr Solutions. In the second season, we discuss the ad promo laws and regulations, offering a consolidated and high-level understanding of the laws in regulated and semi-regulated markets. With dynamic changes in the jurisdictions, compliance with the defined laws and interpretation of the concerned Health Authorities is essential.</p>
<p>Advertising of drugs has been a common practice adopted by pharmaceutical organizations. To protect the public from being manipulated, the Health Authorities introduce various acts to prohibit any illegal promotions. Our host provides an overview of advertising laws and regulations across six jurisdictions.</p>
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Episode 6. Regulatory Compliance - The Future & Next Steps
<p>Health Authorities have accomplished major milestones in the previous decades. Fast-tracked approval of necessary medical products during the pandemic has set a benchmark for Regulatory Authorities to deliver safe and carefully examined medicines to the general population. Such efforts have set into motion a cascade of innovation and experimentation in the future of regulations and compliance. Our experts discuss diverse possibilities and innovations in the Regulatory life sciences space. </p>
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Episode 5. Global & the European Facilitated Regulatory Pathways
<p>Time-to-market plays a major role in addressing the needs of vulnerable patient groups. Facilitated pathways across the globe accelerate the timelines of innovative drug molecules, allowing fast-tracked approval pathways for essential medicines. Our experts address the necessary requirements of innovators and elaborate on the facilitated Regulatory pathways.</p>
<p>Reference Links</p>
<ul><li><a href='https://cirsci.org/wp-content/uploads/dlm_uploads/2021/06/CIRS-RD-Briefing-81-6-agencies-v5.pdf'>Centre for Innovation in Regulatory Science report New drug approvals in six major authorities 2011-2020</a></li>
</ul>
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Episode 4. Monitoring Medicines and Supervisory Committees
<p>Grant of marketing authorizations signals the commencement of the years-long journey of a drug molecule. Post-market authorization activities begin once the molecule has been approved and is fit to use for the patient population. Inspection of a given drug product is of prime importance to keep patient safety at the very core. Our experts express their views regarding monitoring medicines and the supervisory committee within the EMRN.</p>
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Episode 3. Medicinal Products Lifecycle & Regulatory Pathways
<p>Drug development takes decades of planning and experimentation. Different phases of the drug development lifecycle come with their own unique challenges. Phase-by-phase development of a drug molecule ensures that safe and effective medicines enter the patient population. Our experts talk about the phases of the drug development lifecycle from the very initial phase to the end, with a view of simplifying the complex stages of drug development.</p>
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Episode 2. Centralised and Decentralised Procedures
<p>Different approval pathways can be explored while entering the European pharmaceutical market. The approval pathways include:</p>
<ul><li>Centralized Procedure (CP)</li>
<li>Decentralized Procedure (DCP)</li>
<li>National Procedure (NP)</li>
<li>Mutual Recognition Procedure (MRP)</li>
</ul>
<p>Our experts discuss the most explored pathways, CP and DCP, and the eligibility criteria to pursue them for product approval and marketing authorization within the European Union (EU). </p>
<p>Reference Links</p>
<ul><li><a href='https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-european-medicines-agency_en.pdf'>EMA overview of the centralised authorisation procedure</a></li>
<li><a href='https://ec.europa.eu/health/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu/authorisation-procedures-national-authorisation-procedures_en'>European Commission summary of national authorization procedures</a></li>
<li><a href='https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma.html'>CMDh guidance on marketing authorization applications</a></li>
</ul>
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Episode 1. The European Medicines Regulatory Network
<p style="text-align:justify;">Introduction to the European Medicines Regulatory Network (EMRN) across various functions and procedures. Our experts give an overview of different approval pathways and their significance and elaborate on the different networks available within EMRN for drug approvals.</p>
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