{"version":"https://jsonfeed.org/version/1","title":"Indaea.co","home_page_url":"https://indaea.co","description":"Indaea.co","author":{"name":"Indaea.co"},"items":[{"id":"fda-generic-drug-forum-2026-critical-updates-for-anda-success","html_content":"

April 22-23, 2026 | Virtual Event

","url":"https://indaea.co/food-supplements-1/f/fda-generic-drug-forum-2026-critical-updates-for-anda-success","title":"FDA Generic Drug Forum 2026: Critical Updates for ANDA Success","date_modified":"2026-04-24T07:01:01Z"},{"id":"ich-e6r3-a-reimagined-gcp-framework---from-rules-to-principles","html_content":"

The third revision of the international GCP guideline moves beyond procedural compliance to embed proportionality, quality by design, and risk management at the heart of clinical research.

","url":"https://indaea.co/food-supplements-1/f/ich-e6r3-a-reimagined-gcp-framework---from-rules-to-principles","title":"ICH E6(R3): A Reimagined GCP Framework - From Rules to Principles","date_modified":"2026-04-08T13:55:03Z"},{"id":"march-2026-roadmaps-to-mandates-and-what-is-next","html_content":"

As we close out the first quarter of 2026, regulatory professionals in pharmaceuticals and medical devices are navigating a landscape of evolving compliance requirements. March 2026 stands out for its mix of hard deadlin...

","url":"https://indaea.co/food-supplements-1/f/march-2026-roadmaps-to-mandates-and-what-is-next","title":"March 2026: Roadmaps to Mandates and What is Next","date_modified":"2026-03-31T15:51:06Z"},{"id":"biocompatibility-iso-10993-2025-shift-the-industry-cant-ignore","html_content":"

Biocompatibility Planning and Reporting under ISO 10993: Best Practices Guide to BEP, BER, and the Post 2025 Landscape

","url":"https://indaea.co/food-supplements-1/f/biocompatibility-iso-10993-2025-shift-the-industry-cant-ignore","title":"Biocompatibility: ISO 10993 2025 shift, the industry can't ignore","date_modified":"2026-03-25T11:38:20Z"},{"id":"eu-gmp-mahs-responsibilities-and-what-is-coming-next","html_content":"

Introduction: More Than Just a Licence Holder

","url":"https://indaea.co/food-supplements-1/f/eu-gmp-mahs-responsibilities-and-what-is-coming-next","title":"EU GMP: MAH's Responsibilities and What is Coming Next","date_modified":"2026-03-18T13:16:16Z"},{"id":"feb-2026-evolving-mah-role-led-by-patient-safety","html_content":"

The pharmacovigilance landscape is entering a decisive moment for drug safety governance. With Commission Implementing Regulation (EU) 2025/1466 (IR) of 22 July 2025 amending the foundational EU pharmacovigilance framewo...

","url":"https://indaea.co/food-supplements-1/f/feb-2026-evolving-mah-role-led-by-patient-safety","title":"Feb 2026: Evolving MAH Role led by Patient Safety","date_modified":"2026-02-27T12:16:56Z"},{"id":"012026-implementation-deadline-is-your-lcm-strategy-set","html_content":"

From reactivity to proactivity in the whole life-cycle!

","url":"https://indaea.co/food-supplements-1/f/012026-implementation-deadline-is-your-lcm-strategy-set","title":"01/2026 Implementation Deadline: Is your LCM strategy set?","date_modified":"2026-01-30T13:28:01Z"},{"id":"celebrating-data-the-silent-architect-of-tomorrows-healthcare","html_content":"

The future of healthcare is being shaped not only in laboratories, hospitals, or regulatory agencies, but in the expanding universe of data—structured, standardised, interconnected, and ready to inform decisions at every...

","url":"https://indaea.co/food-supplements-1/f/celebrating-data-the-silent-architect-of-tomorrows-healthcare","title":"Celebrating Data: The Silent Architect of Tomorrow's Healthcare","date_modified":"2025-12-11T18:21:16Z"},{"id":"notifications-lcm-strategic-tool-for-agility","html_content":"

The European regulatory environment for medicinal products and medical devices is entering a transformative phase. As the EU shifts toward a more agile, risk-based, and innovation-enabling framework, notifications are em...

","url":"https://indaea.co/food-supplements-1/f/notifications-lcm-strategic-tool-for-agility","title":"Notifications: LCM strategic tool for agility","date_modified":"2025-08-19T13:57:24Z"},{"id":"marketing-authorisation-application-new-regulation---new-rules","html_content":"

The European Union is on the verge of implementing the most significant overhaul of its pharmaceutical legislation in over two decades. With the long-anticipated revision of Regulation (EC) No 726/2004 and Directive 2001...

","url":"https://indaea.co/food-supplements-1/f/marketing-authorisation-application-new-regulation---new-rules","title":"Marketing Authorisation: New Pharma Regulation Redesigning Access","date_modified":"2025-08-06T19:57:58Z"},{"id":"life-cycle-maintenance-from-variation-to-value---new-framework","html_content":"

The European Commission has adopted a long-anticipated revision to the Variations Regulation, marking a transformative step toward a more agile and innovation-friendly post-approval landscape for medicines in the EU.

","url":"https://indaea.co/food-supplements-1/f/life-cycle-maintenance-from-variation-to-value---new-framework","title":"Life-cycle Maintenance: From Variation to Value - New framework","date_modified":"2025-07-30T13:35:27Z"},{"id":"clinical-non-clinical-evidence-where-medtech-pharma-converge","html_content":"

The concept of clinical evidence is central to both medical device development and pharmaceutical innovation. But how we define, generate, and communicate that evidence is evolving. With the updated ICH Good Clinical Pra...

","url":"https://indaea.co/food-supplements-1/f/clinical-non-clinical-evidence-where-medtech-pharma-converge","title":"Clinical & Non-clinical Evidence: Where MedTech & Pharma Converge","date_modified":"2025-07-23T10:20:17Z"},{"id":"joint-clinical-assessment-jca-why-should-we-act-now","html_content":"

Starting in 2026, high-risk medical devices will enter the European Union (EU) Joint Clinical Assessment (JCA) framework, marking a profound shift in how clinical evidence is assessed at the EU level. This transition wil...

","url":"https://indaea.co/food-supplements-1/f/joint-clinical-assessment-jca-why-should-we-act-now","title":"Joint Clinical Assessment (JCA): Why should we act now?","date_modified":"2025-07-16T08:59:55Z"},{"id":"integrated-support-ear-eim-prrc---full-spectrum-eu-compliance","html_content":"

The Benefits of a Combined European Authorised Representative, Importer & PRRC

","url":"https://indaea.co/food-supplements-1/f/integrated-support-ear-eim-prrc---full-spectrum-eu-compliance","title":"Integrated Support: EAR, EIM & PRRC - Full Spectrum EU Compliance","date_modified":"2025-07-09T10:46:51Z"},{"id":"health-technology-assessment-regulation-innovations-new-chapter","html_content":"

Today, 30 June 2025, marks the closing of the second submission window this year for Joint Scientific Consultations (JSCs) under the EU Health Technology Assessment (HTA) Regulation (EU 2021/2282). As the window shuts, i...

","url":"https://indaea.co/food-supplements-1/f/health-technology-assessment-regulation-innovations-new-chapter","title":"Health Technology Assessment: A New Chapter for EU Innovations ","date_modified":"2025-06-30T15:42:22Z"},{"id":"gmp-in-the-eu-post-covid-backlogs-and-current-workloads","html_content":"

This article focuses on GMP compliance in human medicines, with particular attention to the workload rebound following the pandemic period and the evolving role of EMA.

","url":"https://indaea.co/food-supplements-1/f/gmp-in-the-eu-post-covid-backlogs-and-current-workloads","title":"GMP in the EU: Post-COVID Backlogs and Current Workloads","date_modified":"2025-06-12T09:26:35Z"},{"id":"food-supplements-one-directive---local-divergence-in-the-eu","html_content":"

The European Union’s internal market offers immense opportunities for food supplement manufacturers, yet the regulatory path to compliance is anything but uniform.

","url":"https://indaea.co/food-supplements-1/f/food-supplements-one-directive---local-divergence-in-the-eu","title":"Food Supplements: One Directive with Many Faces","date_modified":"2025-06-06T10:38:22Z"},{"id":"environmental-risk-assessment-new-era-regulatory-risk-in-the-eu","html_content":"

Environmental Risk is a New Era Regulatory Risk!

","url":"https://indaea.co/food-supplements-1/f/environmental-risk-assessment-new-era-regulatory-risk-in-the-eu","title":"Environmental Risk Assessment: New Era Regulatory Risk in the EU ","date_modified":"2025-05-29T06:45:32Z"},{"id":"drug-development-nextgen-intelligent-therapeutics---nanorobotics","html_content":"

Advanced Medical Technologies and Therapies

","url":"https://indaea.co/food-supplements-1/f/drug-development-nextgen-intelligent-therapeutics---nanorobotics","title":"Drug Development: Nanorobotics - NextGen Intelligent Therapeutics","date_modified":"2025-05-22T14:32:07Z"},{"id":"cosmetics-your-brand%E2%80%99s-compliance-lifeline---eu-rp-role","html_content":"

Why All Related to Cosmetics in the EU Lead to One Gatekeeper?

","url":"https://indaea.co/food-supplements-1/f/cosmetics-your-brand%E2%80%99s-compliance-lifeline---eu-rp-role","title":"Cosmetics: Your Brand’s Compliance Lifeline - EU RP role","date_modified":"2025-05-05T18:00:40Z"},{"id":"best-practices-in-becoming-an-eu-marketing-authorisation-holder","html_content":"

Obtaining marketing authorization (MA) for a medicinal product in the European Union is a major milestone. But becoming a Marketing Authorisation Holder (MAH) also comes with enduring responsibilities that go far beyond ...

","url":"https://indaea.co/food-supplements-1/f/best-practices-in-becoming-an-eu-marketing-authorisation-holder","title":"Best Practices in Becoming an EU Marketing Authorisation Holder","date_modified":"2025-04-08T17:00:00Z"},{"id":"ai-inspirited-human-centric-healthtech-evolving-with-leads","html_content":"

Artificial Intelligence (AI) is transforming the Healthcare and HealthTech ecosystems in the EU, but still staying focused on Humans: patients, healthcare professionals, and their needs, and challenging the systems to ev...

","url":"https://indaea.co/food-supplements-1/f/ai-inspirited-human-centric-healthtech-evolving-with-leads","title":"AI-inspirited Human-centric HealthTech: Evolving with Leads","date_modified":"2025-02-11T16:59:16Z"},{"id":"comming-soon","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/comming-soon","title":"World-first ISO guidelines empowering SDGs ","date_modified":"2024-10-02T11:31:13Z"},{"id":"e-id-digital-identity-empowering-regulatory-roles-in-the-eu","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/e-id-digital-identity-empowering-regulatory-roles-in-the-eu","title":"e-ID: Digital Identity Empowering EU Regulatory Roles","date_modified":"2024-09-16T13:15:03Z"},{"id":"biosimilars-at-which-level-they-can-be-interchangeable","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/biosimilars-at-which-level-they-can-be-interchangeable","title":"Biosimilars Interchangeability: Where, when & how?","date_modified":"2024-09-16T13:08:48Z"},{"id":"fda-nextgen","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/fda-nextgen","title":"Regulatory Science: Interpreted for all","date_modified":"2024-09-04T05:55:45Z"},{"id":"pv-updates-08-2024","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/pv-updates-08-2024","title":"Expedited Development Programs: What we can do better?","date_modified":"2024-09-03T20:17:58Z"},{"id":"e-pi-latest-updates","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/e-pi-latest-updates","title":"e-PI key principles: Where we are 5 years later? ","date_modified":"2024-09-03T20:14:56Z"},{"id":"cognitive-debriefing-interviews","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/cognitive-debriefing-interviews","title":"Patient Voice. Is it heard enough?","date_modified":"2024-09-02T18:17:29Z"},{"id":"new-pharmaceutical-regulation","html_content":"

Coming soon!

","url":"https://indaea.co/food-supplements-1/f/new-pharmaceutical-regulation","title":"New Pharmaceutical Regulation: Are we on track?","date_modified":"2024-08-15T07:35:58Z"}]}