Ceutico Consulting Services’ Post

Sharing a brilliant article published on the ISPE iSpeak blog. It presents some valuable work and regulatory insights gathered by the Regulatory Quality Harmonization Committee (RQHC) APAC Regional Focus Groups (RFGs). #pharmaceutical #regulatory #harmonisation https://lnkd.in/dZSpzKrw

🔍 𝐋𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐄𝐔 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐋𝐞𝐠𝐢𝐬𝐥𝐚𝐭𝐢𝐨𝐧 𝐑𝐞𝐟𝐨𝐫𝐦   As the pharmaceutical industry stands on the precipice of a transformative era, brought forth by the comprehensive EU pharmaceutical legislation reform, Marloes van Bruggen - van der Geer, Head of Regulatory Affairs at Celegence, gave us her seasoned perspective, to help you traverse the nuances of these regulatory changes. 🎥 Join Marloes as she unveils insights into the challenges anticipated across the pharmaceutical product lifecycle, from the early stages of research to crucial processes of marketing authorization. Get access to firsthand analysis, derived from extensive experience and dialogues with regulatory bodies, illuminating the path forward for navigating the complexities of compliance. 🌐 Access the full webinar, on-demand and learn how you can navigate the new EU regulatory challenges: https://lnkd.in/e3vr25zb 𝐊𝐞𝐲 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐈𝐧𝐜𝐥𝐮𝐝𝐞:  ▶ Challenges in adapting to new regulatory frameworks.   ▶ Navigating the intricacies of cross-departmental impacts.   ▶ Overcoming hurdles in market access and product distribution.   ▶ Enhancing documentation and regulatory processes. Embrace the expertise and cutting-edge solutions offered by Celegence as you look to adapt to the ever-evolving landscape. Our team is equipped to expand your capabilities, ensuring seamless transitions and robust adherence to evolving regulations. With Celegence, amplify your readiness for the demands of #pharmaceuticalregulation and #legislativecompliance. #pharmaceuticals #regulatoryaffairs #compliance #regulatorystrategy #EUlegislation #pharmaindustry #webinars #innovation #healthcarecompliance #medicalregulation #EUpolicy #regulatoryinsights #pharmacovigilance #supplychainmanagement #Celegence 

The GCC Pharmacovigilance Training 2024 brought together industry leaders to discuss crucial topics, including pharmacovigilance updates, patient safety, and regulatory advancements. We were honored to have Dr. Nesrine FRAOUI, whose expertise and leadership at the Agence Nationale des Produits Pharmaceutiques | National Agency for Pharmaceutical Products of Algeria (ANPP) significantly contributed to this year's discussions. Her insights on enhancing vigilance practices and ensuring patient safety have made a profound impact across the region. For more details, visit our website: www.pramagcc.com #GCCPVTraining #GCCPharmacovigilanceTraining #RegulatoryAffairs #PharmaceuticalIndustry #IndustryLeadership #Pharmaceutical #Pharma #GCCRegulatoryAffairsPharmaSummit #Interview #GCC #Algeria #Pharmacovigilance

In regulatory affairs, various international and regional organizations establish guidelines and standards for pharmaceutical manufacturing and quality control. Key organizations include the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the World Health Organization (WHO), and region-specific country groups. Each of these organizations has unique roles, scopes, and impacts on the pharmaceutical industry. Below is a comparative table highlighting these differences from a regulatory affairs perspective: If you need any help contact Ashab Group. Call - 8264941592 #ICH #WHO #regulatoryaffairs #regulatory #regulatorysubmission #regulatorycompliance #regulatoryfiling #regulatoryapproval #CMC #Dossier #pharma #pharmaceutical #drugs #globalfiling

Outsourcing pharmaceutical regulatory affairs can be a smart move for drug development companies. By tapping into the expertise of regulatory professionals, companies can navigate complex regulations more efficiently and focus on their core competencies. This can help them bring new drugs to market faster, improve compliance, and reduce costs. At EVKA, we have a team of experts who are knowledgeable about the local regulatory landscape in Kenya. We can provide you with guidance and support throughout the submission process, from preparing your dossier to navigating any issues that may arise during the review process. If you're a pharmaceutical company planning to submit a product for approval in Kenya, contact us today on 073241324 to learn more about how we can help you achieve regulatory compliance and ensure a successful submission. #RegulatorySubmissions #Pharmaceuticals #Kenya #regulatoryaffairs #drugdevelopment #outsourcing

In regulatory affairs, various international and regional organizations establish guidelines and standards for pharmaceutical manufacturing and quality control. Key organizations include the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the World Health Organization (WHO), and region-specific country groups. Each of these organizations has unique roles, scopes, and impacts on the pharmaceutical industry. Below is a comparative table highlighting these differences from a regulatory affairs perspective: #ICH #WHO #regulatoryaffairs #regulatory #regulatorysubmission #regulatorycompliance #regulatoryfiling #regulatoryapproval #CMC #Dossier #pharma #pharmaceutical #drugs #globalfiling

Navigating the complexities of European market requirements for pharmaceutical companies is anything but straightforward. My colleague Regina Dawkins (Dempsey) speaks about bringing innovations into the European market where the management of stringent regulations to ensure compliance with varying national standards, is crucial and the journey sometimes full of hurdles. It's about balancing innovation with safety, understanding market access, and adapting to ever-evolving policies. Success requires not just a deep knowledge of the regulatory landscape but also agility and foresight. Patience and precision are key. #Pharma #EuropeanMarket #Compliance #RegulatoryAffairs #Pharmaceuticals #Innovation

Join us to explore the latest trends, innovations, and opportunities in the pharmaceutical industry. Let's connect, collaborate, and create new partnerships that drive the future of healthcare. #CPhIChina #Pharmaceuticals #PharmaGreenfieldConsultancy #Networking #PharmaIndustry #qualitymanagement #qualityassurance #qualitycontrol #GMP #compliance #regulatorycompliance #qualityassurance #pharmaceutical #pharmaceuticals #pharmaceuticalindustry #pharma #gxp #consulting #pharmaindustry #pharmazone #gmpauditreports #gmpaudit #vendorqualification #vendorapproval #thirdpartyauditreport #USFDA #EMA #RegulatoryAffairs #regulatorycompliance #supplierquality #supplierriskmanagement #supplychainmanagement #API #intermediates #excipients #CMO #cGMP #ICHQ7 #Eudralex #PICS #MHRA #auditreports #remoteaudit #ICH #QualifiedPerson #RegulatoryRequirements #Dossier #eCTD #CEP #DMF #ASMF

Bringing a biopharmaceutical product to the European Union market involves navigating a complex regulatory landscape. Non-EU companies accustomed to single-agency frameworks like the FDA or PMDA may find EU requirements particularly challenging. Explore our latest article by experts Monica Buchberger and Dr. Stephen Sun to gain key insights on: • Understanding the intricate EU pharmacovigilance (PV) system • Strategies for market entry - including the benefits of outsourcing PV activities • Exploring different pathways for product authorization • Adhering to local PV requirements and the critical role of the Qualified Person for Pharmacovigilance (QPPV) Discover how to ensure compliance and successful market entry in the EU by reading the full article here: https://lnkd.in/dnEDqPuG #PharmaLex #EUMarket #Pharmacovigilance #Biopharmaceuticals #RegulatoryCompliance #MarketEntry #PharmaIndustry

In the field of regulatory affairs, various international and regional organizations set guidelines and standards for pharmaceutical manufacturing and quality control. These include the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the World Health Organization (WHO), and region-specific country groups. Each of these bodies has distinct roles, scopes, and impacts on the pharmaceutical industry. Below is a comparative table outlining these differences from a regulatory affairs perspective: #ICH #WHO #regulatoryaffairs #regulatory #regulatorysubmission #regulatorycompliance #regulatoryfilling #regulatoryapproval #CMC #Dossier #pharma #pharmaceutical #drugs #globalfilling