Blog | Regulatory Affairs

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</div> <div class="listing-post"> <div class="article"> <div class="article__thumbnail "> <a href="https://blog.pqegroup.com/regulatory-affairs/ivdr-what-does-it-mean-for-manufacturers-of-in-vitro-diagnostic-devices"> <div class="category-container"> <div class="tag regulatory_affairs" href="https://blog.pqegroup.com/tag/regulatory-affairs">Regulatory Affairs</div> </div> <img class="featured-post-image" src="https://blog.pqegroup.com/hubfs/IVDR%20Regulation_Banner%20new.jpg"> </a> </div> <div class="article__text"> <div class="article__date">12 Dec 2024</div> <a href="https://blog.pqegroup.com/regulatory-affairs/ivdr-what-does-it-mean-for-manufacturers-of-in-vitro-diagnostic-devices"> <h2 class="article__title">IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices?</h2> <p class="article__excerpt">The transition to IVDR introduces new challenges for IVD manufacturers, with stricter requirements and revised timelines to ensure compliance</p> </a> <div 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'width=600,height=500')" class="twitter">  <img src="https://blog.pqegroup.com/hubfs/twitter-1.png" style="width: 13px" alt="twitter"> </a> </div> </div> </div> </div> <div class="listing-post"> <div class="article"> <div class="article__thumbnail "> <a href="https://blog.pqegroup.com/regulatory-affairs-farmacovigilancia/medicines-in-europe-registration-lifecycle-management-and-extension"> <div class="category-container"> <div class="tag regulatory_affairs" href="https://blog.pqegroup.com/tag/regulatory-affairs">Regulatory Affairs</div> </div> <img class="featured-post-image" src="https://blog.pqegroup.com/hubfs/Medicines%20in%20Europe_Banner_1.jpg"> </a> </div> <div class="article__text"> <div class="article__date">23 Oct 2024</div> <a href="https://blog.pqegroup.com/regulatory-affairs-farmacovigilancia/medicines-in-europe-registration-lifecycle-management-and-extension"> <h2 class="article__title">Medicines in Europe: Registration, lifecycle Management and Extension</h2> <p class="article__excerpt">Medicines in Europe need Marketing Authorization and ongoing safety monitoring to ensure compliance and patient safety.</p> </a> <div class="social-sharing-icon-list"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/regulatory-affairs-farmacovigilancia/medicines-in-europe-registration-lifecycle-management-and-extension&title=Medicines%20in%20Europe:%20Registration,%20lifecycle%20Management%20and%20Extension&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Medicines%20in%20Europe_Banner_1.jpg&description=Medicines%20in%20Europe%20need%20Marketing%20Authorization%20and%20ongoing%20safety%20monitoring%20to%20ensure%20compliance%20and%20patient%20safety." title="Share on Facebook" target="_blank" onclick="return !window.open(this.href, 'Facebook', 'width=600,height=500')" class="facebook"><i class="fa fa-facebook"></i></a> <a 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<img src="https://blog.pqegroup.com/hubfs/twitter-1.png" style="width: 13px" alt="twitter"> </a> </div> </div> </div> </div> <div class="listing-post"> <div class="article"> <div class="article__thumbnail "> <a href="https://blog.pqegroup.com/ra-phv/new-ich-q2-r2-and-ich-q14"> <div class="category-container"> <div class="tag regulatory_affairs" href="https://blog.pqegroup.com/tag/regulatory-affairs">Regulatory Affairs</div> </div> <img class="featured-post-image" src="https://blog.pqegroup.com/hubfs/New%20ICH%20Q2_Site%20Banner.jpg"> </a> </div> <div class="article__text"> <div class="article__date">05 Jun 2024</div> <a href="https://blog.pqegroup.com/ra-phv/new-ich-q2-r2-and-ich-q14"> <h2 class="article__title">New ICH Q2 (R2) and ICH Q14: a Step Forward Towards the Validation of Analytical Methods</h2> <p class="article__excerpt">New ICH Q2 (R2) and ICH Q14 set to revolutionize analytical method validation in the pharmaceutical industry, enhancing quality, safety, and.</p> </a> <div 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including regulatory requirements, study types, and.</p> </a> <div class="social-sharing-icon-list"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/ra-phv/clinical-and-pre-clinical-trials-for-veterinary-medicinal-products&title=Clinical%20and%20Pre-clinical%20trials%20for%20Veterinary%20Medicinal%20Products&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Vet%20GABA_1_Site%20Banner.jpg&description=Learn%20about%20the%20importance%20of%20clinical%20and%20pre-clinical%20trials%20for%20veterinary%20medicinal%20products,%20including%20regulatory%20requirements,%20study%20types,%20and%20investment%20protection." title="Share on Facebook" target="_blank" onclick="return !window.open(this.href, 'Facebook', 'width=600,height=500')" class="facebook"><i class="fa fa-facebook"></i></a> <a 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learn how embracing digital technologies revolutionizes industry operations.</p> </a> <div class="social-sharing-icon-list"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/ra-phv/the-impact-of-digitalization-in-pharmaceutical-regulatory-affairs&title=The%20Impact%20of%20Digitalization%20in%20Pharmaceutical%20Regulatory%20Affairs&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Digitalization%20in%20Pharmaceutical%20Regulatory%20Affairs_Site%20Banner.jpg&description=From%20streamlining%20processes%20to%20enhancing%20data%20analytics,%20learn%20how%20embracing%20digital%20technologies%20revolutionizes%20industry%20operations." title="Share on Facebook" target="_blank" onclick="return !window.open(this.href, 'Facebook', 'width=600,height=500')" class="facebook"><i class="fa fa-facebook"></i></a> <a 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class="article__text"> <div class="article__date">22 Jan 2024</div> <a href="https://blog.pqegroup.com/ra-phv/what-is-spor"> <h2 class="article__title">What is SPOR?</h2> <p class="article__excerpt">Learn about SPOR (Substance, Product, Organization and Referential), the European Medicines Agency's requirement for implementing ISO IDMP standards..</p> </a> <div class="social-sharing-icon-list"> <a 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Be prepared to submit the variations</h2> <p class="article__excerpt">The EMA has introduced the QRD Template Version 9.0 for product information used by the MAH. 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src="https://blog.pqegroup.com/hubfs/banner%20insghits_Environmental%20Risk%20Assessment%20of%20Medical%20Products%20for%20Human%20Use_1-1.jpg"> </a> </div> <div class="article__text"> <div class="article__date">23 Aug 2023</div> <a href="https://blog.pqegroup.com/ra-phv/environmental-risk-assessment-of-medical-products-for-human-use"> <h2 class="article__title">Environmental Risk Assessment of Medical Products for Human Use: Comparison between EMA & FDA Requests</h2> <p class="article__excerpt">The important role of Environmental risk assessment (ERA) before applying for marketing authorization in Europe and in the United States.</p> </a> <div class="social-sharing-icon-list"> <a 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