# Regulatory Affairs * **Definition:** A field that ensures compliance with regulations and laws governing the life sciences industry, involving the regulation of products to ensure they meet necessary legal and safety standards before they can be marketed. * **Taxonomy:** Healthcare Topics / Regulatory Affairs ## News * Selected news on the topic of **Regulatory Affairs**, for healthcare technology leaders * 8.6K news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 4/24/2025 | [**Regulatory Affairs Outsourcing Market Projected to Reach USD 13.56 Billion by 2030, Driven by Increasing Complexity in Regulatory Landscapes**](http://prsync.com/maximize-market-research---mc/regulatory-affairs-outsourcing-market-projected-to-reach-usd--billion-by--driven-by-increasing-complexity-in-regulatory-landscap-4726903/) | [[PRSync]] | | 4/17/2025 | [**City Therapeutics Expands Executive Team and Board of Directors - Yahoo Finance**](https://finance.yahoo.com/news/city-therapeutics-expands-executive-team-120000467.html) | [[Yahoo Finance]] | | 3/19/2025 | [**HiRO and Hallym University Sacred Heart Hospital Sign Strategic MOU to Advance Drug Development**](https://www.prnewswire.com/news-releases/hiro-and-hallym-university-sacred-heart-hospital-sign-strategic-mou-to-advance-drug-development-302406472.html) | [[PR Newswire]] | | 3/19/2025 | [**HiRO and Hallym University Sacred Heart Hospital Sign Strategic MOU to Advance Drug ...**](https://www.prnewswire.com/apac/news-releases/hiro-and-hallym-university-sacred-heart-hospital-sign-strategic-mou-to-advance-drug-development-302406476.html) | [[PR Newswire]] | | 3/13/2025 | [**CRDMO Market Research 2025: A Highly Competitive $328 Billion Market by 2029 with ...**](https://finance.yahoo.com/news/crdmo-market-research-2025-highly-153900056.html) | [[Yahoo Finance]] | | 1/10/2025 | [**China Pharmaceutical Regulatory Affairs Training Course: How to Gain and Maintain a Successful Marketing Authorisation in the PRC, Including Hong Kong, Macau and Taiwan (ONLINE EVENT: April 8-9, 2025) - ResearchAndMarkets.com**](http://www.businesswire.com/news/home/20250110103738/en/China-Pharmaceutical-Regulatory-Affairs-Training-Course-How-to-Gain-and-Maintain-a-Successful-Marketing-Authorisation-in-the-PRC-Including-Hong-Kong-Macau-and-Taiwan-ONLINE-EVENT-April-8-9-2025---ResearchAndMarkets.com/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 12/19/2024 | [**mHealth Solutions Market Forecast: Insights on Growth Factors and 13.9AGR through 2031**](https://www.linkedin.com/pulse/mhealth-solutions-market-forecast-insights-growth-factors-8vkbe) | [[Linkedin]] | | 12/7/2024 | [**With an anticipated CAGR of 7.5the Invasive Blood Pressure Monitoring Sensors Market ...**](https://www.linkedin.com/pulse/anticipated-cagr-75-invasive-blood-pressure-monitoring-ymmbe) | [[Linkedin]] | | 12/2/2024 | [**All About FDA Data Integrity by Design Course: What is Next for the Modernization ... - Business Wire**](https://www.businesswire.com/news/home/20241202190741/en/All-About-FDA-Data-Integrity-by-Design-Course-What-is-Next-for-the-Modernization-of-the-Processes-Involved-in-Compliance-for-FDA-regulated-Systems-ONLINE-EVENT-December-9-10-2024ON-DEMAND---ResearchAndMarkets.com) | [[Business Wire]] | | 11/27/2024 | [**Comprehensive Examination of the Healthcare Software As A Service Market - LinkedIn**](https://www.linkedin.com/pulse/comprehensive-examination-healthcare-software-service-bpitc) | [[Linkedin]] | | 11/14/2024 | [**More Than a Third of Organizations at Risk of Non-Compliance as Regulatory Complexity Reaches New Heights, Reveals RegASK's Latest Report**](http://www.businesswire.com/news/home/20241114985518/en/More-Than-a-Third-of-Organizations-at-Risk-of-Non-Compliance-as-Regulatory-Complexity-Reaches-New-Heights-Reveals-RegASK%E2%80%99s-Latest-Report/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 11/13/2024 | [**ALX Oncology Appoints Alan Sandler, M.D., as Chief Medical Officer**](https://markets.businessinsider.com/news/stocks/alx-oncology-appoints-alan-sandler-m-d-as-chief-medical-officer-1034017249) | [[Business Insider Markets]] | | 8/14/2024 | [**Thermo Fisher Scientific's Clinical Research Business Recognized by ISG for Digital ...**](https://finance.yahoo.com/news/thermo-fisher-scientific-clinical-research-201500580.html) | [[Yahoo Finance]] | | 8/14/2024 | [**Thermo Fisher Scientific's Clinical Research Business Recognized by ISG for Digital Services Leadership**](http://www.businesswire.com/news/home/20240814919656/en/Thermo-Fisher-Scientific%E2%80%99s-Clinical-Research-Business-Recognized-by-ISG-for-Digital-Services-Leadership/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 8/14/2024 | [**Thermo Fisher Scientific's Clinical Research Business Recognized by ISG for Digital Services Leadership**](https://www.businesswire.com/news/home/20240814919656/en/Thermo-Fisher-Scientific%E2%80%99s-Clinical-Research-Business-Recognized-by-ISG-for-Digital-Services-Leadership) | [[Business Wire]] | | 8/13/2024 | [**Seaport Therapeutics Appoints David Wheadon, M.D., to its Board of Directors**](http://www.businesswire.com/news/home/20240813013615/en/Seaport-Therapeutics-Appoints-David-Wheadon-M.D.-to-its-Board-of-Directors/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 8/12/2024 | [**Medical Device Regulatory Affairs Market Expected to Exceed USD 13.58 Billion by 2031 As ...**](https://www.whatech.com/og/markets-research/medical/865594-surging-demand-medical-device-regulatory-affairs-market-expected-to-exceed-usd-13-58-billion-by-2031.amp.html) | whatech.com | | 8/12/2024 | [**Surging Demand: Medical Device Regulatory Affairs Market Expected to Exceed USD 13.58 ...**](https://www.whatech.com/og/markets-research/medical/865594-surging-demand-medical-device-regulatory-affairs-market-expected-to-exceed-usd-13-58-billion-by-2031.html) | whatech.com | | 8/7/2024 | [**Functional Service Providers (FSP) Market 2024-2031 - Transform Your Business Strategy with InsightAce Analytic Detailed Report**](https://www.prnewswire.com/news-releases/functional-service-providers-fsp-market-2024-2031--transform-your-business-strategy-with-insightace-analytic-detailed-report-302216663.html) | [[PR Newswire]] | | 8/3/2024 | [**Medical Device Regulatory Affairs Industry: In-Depth Exploration of Regulatory Compliance ...**](https://www.whatech.com/og/markets-research/medical/862352-medical-device-regulatory-affairs-industry-in-depth-exploration-of-regulatory-compliance-quality-assurance-risk-management-and-market-access-strategies.html) | whatech.com | | 7/17/2024 | [**Healthcare Contract Research Organization Market Size, Share & Growth Report 2033**](https://www.biospace.com/healthcare-contract-research-organization-market-size-share-growth-report-2033) | biospace.com | | 7/11/2024 | [**Regulatory Affairs Outsourcing Market Advancements Highlighted by Detailed Size and ...**](https://www.whatech.com/og/markets-research/medical/855015-regulatory-affairs-outsourcing-market-detailed-size-and-forecast-report-for-2030) | whatech.com | | 6/28/2024 | [**Incorporating Regulatory Affairs Into Your Quality Management System, Upcoming Webinar Hosted by Xtalks**](https://www.prweb.com/releases/incorporating-regulatory-affairs-into-your-quality-management-system-upcoming-webinar-hosted-by-xtalks-302185347.html) | [[PRWeb]] | | 6/26/2024 | [**Neurona Therapeutics Appoints Dr. Nadia Agopyan as Senior Vice President of Regulatory Affairs**](https://www.globenewswire.com/news-release/2024/06/26/2904808/0/en/Neurona-Therapeutics-Appoints-Dr-Nadia-Agopyan-as-Senior-Vice-President-of-Regulatory-Affairs.html) | [[Globe Newswire]] | | 7/13/2020 | [**Successful CMC Regulatory Affairs**](https://www.news-medical.net/whitepaper/20200714/Successful-CMC-Regulatory-Affairs.aspx) | [[News Medical Net]] | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **RegASK**: A provider of regulatory intelligence solutions, highlighting the challenges faced by regulatory affairs professionals. - **QPS Holdings**: A company enhancing collaboration across its global medical affairs, regulatory affairs, and clinical operations. - **ArisGlobal**: A technology company advocating for the adoption of AI in regulatory affairs to improve compliance and efficiency. - **Data Recognition Corporation**: Selected by the Regulatory Affairs Professionals Society for developing examination services to enhance certification quality. - **ELIQUENT Life Sciences**: A consulting firm formed from six global regulatory consultancies, focusing on regulatory affairs and compliance services. - **Nadia Agopyan, Ph.D., RAC**: Senior Vice President of Regulatory Affairs at Neurona Therapeutics, with over 20 years of experience in global regulatory strategy for drugs and biologics. - **Amarna Therapeutics**: A biotechnology company focused on gene therapies for genetic diseases, forming a Scientific Advisory Board to support regulatory affairs. - **Worldwide Clinical Trials**: A global contract research organization focusing on enhancing quality assurance in clinical trials. - **Polyrizon Ltd.**: A biotech company focused on innovative intranasal hydrogels, enhancing its regulatory affairs team. - **Holland & Knight**: A law firm enhancing its regulatory practice by adding John Vaughan, who has extensive experience in compliance and regulatory affairs in healthcare. - **Coronado Research**: A consultancy-led organization focusing on optimizing drug development pathways through regulatory strategy and advanced analytics. - **Frost & Sullivan**: A research and consulting firm that awarded IQVIA for its commitment to quality in regulatory affairs. - **European Federation of Pharmaceutical Industries and Associations (EFPIA)**: An industry association that represents the pharmaceutical sector in Europe, playing a crucial role in shaping regulatory frameworks like the EU AI Act. - **IQVIA**: A global leader in healthcare data analytics and technology, recognized for its AI-driven quality and regulatory solutions. - **Harvest Integrated Research Organization (HiRO)**: Collaborating with CHA University Bundang Medical Center to streamline clinical trial processes, enhancing regulatory compliance. - **InnoScot Health**: A healthcare innovation firm enhancing regulatory expertise in medical device development. - **Thermo Fisher Scientific**: Recognized for its contributions to clinical development and patient engagement, utilizing advanced technology solutions in regulatory processes. - **Polyrizon**: A biotech company specializing in innovative intranasal hydrogels, navigating the global regulatory landscape. ### Partnerships and Collaborations - **Regulatory Affairs Professionals Society and Data Recognition Corporation**: A partnership to improve the quality and efficiency of exam development for regulatory affairs professionals. - **QPS Holdings**: Enhancing collaboration across its global medical affairs and regulatory affairs units. - **Argosy Healthcare Partners and Connect Life Sciences**: Formed a partnership to enhance recruitment capabilities in regulatory affairs and other life sciences sectors. - **Amarna Therapeutics SAB**: Formed a Scientific Advisory Board to support its gene therapy program, leveraging expertise in regulatory affairs. - **Worldwide Clinical Trials and Kellie MacLeod**: Kellie MacLeod appointed as EVP of Global Quality Assurance to enhance compliance programs. - **HiRO and CHA University**: A Memorandum of Understanding to collaborate on cross-border clinical trial solutions, enhancing regulatory efficiency. - **InnoScot Health**: Collaborating with NHS Scotland and universities to provide strategic advice on regulatory compliance. - **Children's Hospital Colorado and University of Colorado Anschutz Medical Campus**: Established the Colorado Child Health Research Institute to enhance interdisciplinary research and improve regulatory affairs in child health. - **Harvest Integrated Research Organization and CHA University Bundang Medical Center**: Collaboration to provide comprehensive clinical trial solutions for global biotech and pharmaceutical companies. - **Cosmos Health and ZENDON**: A distribution agreement where ZENDON will manage regulatory affairs and distribution for Cosmos Health's products in several European countries. - **HiRO and Hallym University**: A Memorandum of Understanding to foster innovation in drug research and improve clinical trial efficiency. - **Trustworthy Technology and Innovation Consortium (TTIC)**: A collaborative effort aimed at promoting the responsible use of technology in healthcare, ensuring compliance with regulatory standards. - **Visibly and EU Optical Organizations**: Visibly aims to partner with leading EU optical organizations to enhance digital solutions for eye care professionals. - **Project-COMFORT**: A public-private partnership aimed at revolutionizing blood collection and diagnostics through innovative microsampling technology. - **Siemens Healthineers and The Ohio State Wexner Medical Center**: A 10-year partnership focused on developing innovative technologies in diagnostic imaging and artificial intelligence. ### Innovations, Trends, and Initiatives - **Regulatory Affairs Outsourcing Growth**: The market is projected to grow significantly due to increasing regulatory complexities and the need for accelerated product approvals. - **Regulatory Affairs Training**: Courses aimed at providing comprehensive understanding of FDA procedures for pharmaceutical sales in the US. - **Medical Affairs Outsourcing Market**: Expected growth driven by increased R&D activities and stringent regulatory compliance requirements, leading to outsourcing of medical affairs functions. - **Webinar on Regulatory Affairs and Quality Management**: Aimed at enhancing compliance and operational efficiency in life sciences, focusing on the integration of regulatory and quality systems. - **Growth of Regulatory Affairs Outsourcing Market**: Projected to grow by USD 16,605 million by 2030, driven by the increasing complexity of regulatory frameworks. - **Pharmaceutical Regulatory Affairs in Asia Training Course**: A training initiative aimed at providing insights into unique regulatory processes in Asian markets. - **AI in Regulatory Affairs**: AI adoption is seen as a transformative opportunity for organizations to navigate the evolving regulatory landscape. - **Medical Device Regulatory Affairs Market**: Expected to grow from $6.08 billion in 2023 to over $13.58 billion by 2031, indicating a rising demand for regulatory expertise. - **Global Handbook of Medical Devices Regulatory Affairs**: A comprehensive resource for navigating medical device regulations across over 70 countries. - **R&D Cloud**: EDETEK's innovative software ecosystem integrates clinical informatics and regulatory affairs to enhance clinical trial efficiency. - **FDA's RMAT designation**: NRTX-1001 received this designation, highlighting the importance of regulatory pathways for regenerative therapies. - **FDA Modernization Program**: An initiative to enhance technology and processes for compliance in FDA-regulated industries. - **EU AI Act**: A regulatory framework established by the European Union to ensure the ethical and safe deployment of AI technologies in healthcare, fostering innovation while safeguarding patient well-being. - **Remote Patient Monitoring Services**: Projected annual growth rate of 5.8% from 2024 to 2031, emphasizing the importance of regulatory compliance with healthcare regulations like HIPAA. - **CE Mark Approval**: Visibly's VDAP received CE Mark Approval, confirming compliance with EU Medical Device Regulation, facilitating access to vision care. - **SmartSolve®**: IQVIA's platform that simplifies quality and regulatory compliance through an intelligence-driven approach. - **Blockchain and IoT in Clinical Research**: Emerging technologies that enhance data integrity, security, and streamline supply chain management. - **Artificial Intelligence Act in the EU**: Set to come into force on August 1, 2024, requiring businesses to prepare for compliance with new regulations impacting various sectors, including healthcare. - **Decentralized Clinical Trials (DCTs)**: A growing trend in clinical research that enhances participant recruitment and retention through remote participation, driven by technological advancements. ### Challenges and Concerns - **Regulatory Complexity**: 42% of regulatory affairs professionals have missed a regulatory requirement, highlighting the challenges of keeping up with expanding regulations. - **Compliance with Evolving Regulations**: Companies must continuously adapt to changing regulatory environments to ensure compliance and successful product approvals. - **Skilled Workforce Demand**: The CRDMO sector is challenged by the increasing demand for skilled professionals in regulatory affairs and advanced therapies. - **Stringent Regulatory Requirements**: A significant challenge for CMOs and CROs, impacting their operations and necessitating compliance with complex regulations. - **Regulatory Hurdles**: Decentralized clinical trials face challenges related to regulatory compliance and data privacy, which need to be addressed through innovative solutions. - **Vendor Management Issues**: Challenges in managing vendor relationships can hinder efficiency and regulatory compliance in the medical device sector. - **Non-compliance Consequences**: Missed regulatory requirements can lead to delayed product launches and reputational damage. - **Regulatory Compliance**: Healthcare organizations face stringent regulatory requirements that can hinder the adoption of new technologies, including AI and cloud solutions. - **AI Adoption Barriers**: Outdated mindsets and misconceptions about AI capabilities hinder progress in regulatory affairs. - **Compliance Risks**: 62% of professionals have seen an increase in regulations, with many feeling at risk of non-compliance due to unawareness. - **Data Security and Privacy**: Concerns regarding the protection of patient data and compliance with regulations like HIPAA and GDPR in the context of healthcare technology. - **Resource Limitations for SMEs**: Small and medium-sized enterprises struggle with resource limitations and inconsistent regulations across regions. - **Cybersecurity Risks**: Increased vulnerabilities in the software supply chain, necessitating thorough cybersecurity risk assessments during mergers and acquisitions. - **Cost Pressures on FSPs**: Functional Service Providers face cost pressures due to competition and regulatory demands, impacting their ability to deliver high-quality services. - **Cybersecurity Threats**: Increasing cybersecurity threats in healthcare prompt the need for minimum cybersecurity standards and compliance with long-term data retention requirements. - **Data Security**: Concerns regarding data privacy and security are paramount, especially with the increasing use of digital health technologies and cloud computing. - **Integration with Legacy Systems**: Challenges in integrating new technologies with existing systems can impede the growth of innovative solutions in healthcare. - **Talent Shortage**: The healthcare industry faces a significant shortage of skilled professionals who can integrate technology with patient care, complicating digital health advancements. ## Related Topics [[Regulatory Compliance]]; [[Regulatory Approvals]]