GCC Regulatory Affairs Pharma Summit’s Post

Risk-based approaches – including collaborative reviews, worksharing and reliance - are considered an important part of the regulatory toolkit to facilitate timely patient access to medicines. While these approaches are well-developed concepts for agencies, how to implement them in practice is not always clear.   Earlier this year, CIRS brought together senior representatives from regulatory agencies, pharmaceutical companies and academia from 18 countries across the Americas, Africa, Asia and Europe, to examine risk-based approaches in more detail. The aim was to identify what is needed for risk-based approaches to work effectively and efficiently, incorporating lessons learned from the various models being implemented around the world.   This synopsis summarises key messages from the workshop, including recommendations on: 🌎 Regional risk-based models 💭 Changing mindsets towards risk-based models 🤝 Good collaborative practices #RegulatoryScience #RegulatoryReliance #pharmaceuticals #RegulatoryAffairs

📌 WEBINAR RECORDING | International Expansion in the UK Pharmaceutical Market: News and Opportunities     🎥 Watch ASPHALION expert Mireia Roig Aubert in this #webinar, delving into the latest developments and opportunities offered by the #UK #pharmaceuticalmarket and discover #keystrategies for #internationalexpansion.      ☺️ We would like to thank everyone for the interest shown in our #webinars and we look forward to sharing more #knowledgeandexperience with our audience!     👀 You can now watch the “International Expansion in the UK Pharmaceutical Market: News and Opportunities” Webinar here ⤵️:     https://bit.ly/3wzI6Nt 📧 For further information, please feel free to contact us at: info@asphalion.com     #WEBINAR #FreeWebinar #Procedures #InternationalStrategies #InternationalExpansion #News #Opportunities #Updates #Regulatory #MeetTheExpert #RegulatoryProcedures #MeetTheExpert #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience  

Dr. Eman Hussien , Regulatory Administration Director at the Center Administration of Pharmaceutical Affairs - Egyptian Drug Authority, was a speaker this year at the annual 9th edition of the GCC Regulatory Affairs Pharma Summit 2024, where industry leaders gathered to discuss important topics such as regulatory affairs and its impact on the pharmaceutical industry. We were delighted to have her with us onboard, and to have her valuable feedback and informative insights on regulatory updates presented at the summit; we look forward for this presence and participation, again next year. For more information and news about the summit, please visit our website: www.pramagcc.com #RegulatoryAffairs #PharmaceuticalIndustry #IndustryLeadership #Pharmaceutical #Pharma #GCCRegulatoryAffairsPharmaSummit #interview #GCC #Egypt

SBIA | FDA Releases Webinar on the Office of Pharmaceutical Quality Reorganization The U.S. Food and Drug Administration is announcing a webinar on the reorganization of the Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ). This reorganization was implemented in January and does not result in any direct or immediate changes for individuals outside of FDA, including drug manufacturers. This reorganization enables OPQ to evolve and adapt to the ever-changing global health care landscape and:  Streamline processes and systems for enhanced efficiency, eliminating operational redundancies and bottlenecks Embrace new technologies and tools as the key to staying ahead in a dynamic environment. Actively pursue innovation to make a meaningful difference in patients' lives Adopt a culture of continuous improvement, in which OPQ is consistently seeking better and more efficient ways of working and advancing the field   OPQ restructured to increase its ability to respond to changes in workload, increasing complexity of pharmaceutical supply chains, and public health emergencies. OPQ created five new offices to allow quick response to demands and public health needs and allow for an integrated quality assessment of products throughout their lifecycle. This webinar describes OPQ’s new structure and how it continues to advance drug quality. #fda #quaIity #office #reorganization #webinar https://lnkd.in/g9KbmSPh

I am so grateful to share that I have masterfully completed the esteemed Course ✨ "Managing Conflict of Interest in National Pharmaceutical Systems" ✨offered by World Health Organization ✨✨ 📢I am highlighting some learning goals of this course: 👉Address what a COI in the context of the public pharmaceutical system is and identify potential adverse outcomes associated with these COIs 👉Explain the need for preventing and mitigating these COIs 👉Describe practical guidance provided by WHO on how to prevent and manage COIs in the public pharmaceutical system. 👉Outline current COI issues in countries, and reflect on approaches to address them 👉Adapt and apply good practices for preventing and managing COIs in the public pharmaceutical system. #Worldhealthorganization #WHO #Conflicts #Pharmaceuticals #Industries #Pharma #Medical #publicpharmaceuticalscompanies

To guarantee that #patients have access to safe, efficient, and high-quality generics, the FDA highlights how important it is to advance the development of complicated #genericdrugs. There is a drive for early interaction between generic #medicine makers and #regulatory agencies due to the recognition of the significant expenditure in #researchanddevelopment needed. The #FDA's #CDER Office of Generic Drugs and the European Medicines Agency have launched a voluntary pilot program, which is a noteworthy step in this direction. The objective of this program is to enable concurrent dialogues between applicants for generic drugs and various #regulatory bodies, with a particular focus on enhancing accessibility to complicated generics, which the #EMA also refers to as "#hybrid medicines." This initiative builds on the partnership that already exists through the Parallel Scientific Advice program, highlighting a mutual commitment to improving patient access to these essential medications. Connect, Repost & Follow for more info on the pharmaceutical industry 🌍 #pharma #pharmaceutical #pharmaindustry #europe #pharmaceuticalindustry #healthcare

New HMA-EMA Catalogs Featuring Real-World Data Sources and Studies Introduced The launch of new catalogs by the HMA and EMA aims to enhance the use and transparency of real-world data in medicines regulation, research, and pharmaceutical development. The catalogs provide resources for identifying data sources and accessing ongoing and completed research. They adhere to FAIR data principles and offer improved search and submission functions. These developments align with the European medicines regulatory network's shift towards a data-driven approach and are expected to improve healthcare outcomes and foster the safe use of medicines. For more details please click the link! https://lnkd.in/dqqRvVwW #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Manufacturing within the pharmaceutical sector across Europe is experiencing continued growth. 🌱💊 From cutting-edge research to innovative production processes, European manufacturers are setting high benchmarks for global pharmaceutical production. 🏭 The sector's growth is not only driving economic development but also serving as a cornerstone for healthcare advancements across the continent. ⚕️ As per recent studies, the pharmaceutical industry in Europe is projected to grow steadily, creating new opportunities for skilled professionals and fostering innovation in drug development. 📈 With a strong emphasis on regulatory compliance and product quality, the European pharmaceutical manufacturing sector stands out as a leader in the global market. 🌍 Let's keep an eye on the exciting developments within this vital industry as it continues to make significant contributions to healthcare worldwide. #PharmaEurope #ManufacturingGrowth #HRSEurope

I’m thrilled to share that I’ve received a certificate of attendance from the Saudi Society of Clinical Pharmacy for attending the workshop titled : "Pharmaceutical Innovation Journey: A Regulatory Perspective". This workshop provided valuable insights into the regulatory framework of pharmaceutical innovation, and I’m grateful for the opportunity to enhance my knowledge in this vital area. A huge thanks to the organizers and speakers for their insights and for sharing their experiences. I look forward to applying what I've learned to contribute to advancements in our field! #PharmaceuticalInnovation #ClinicalPharmacy #SSCP #RegulatoryPerspective

I'm excited to share my latest blog post: [Understanding ICH and Its Role in Global Pharmaceutical Regulation](https://lnkd.in/dPX_yESG) In this post, I dive deep into the International Council for Harmonisation (ICH) and its critical impact on the global pharmaceutical landscape. Discover how ICH guidelines streamline drug development, ensure quality, and enhance patient safety worldwide. Key takeaways: 🔹 What ICH is and its mission 🔹 The significance of harmonized guidelines 🔹 How ICH influences regulatory processes globally Whether you're a regulatory professional, a pharmaceutical enthusiast, or just curious about the intricacies of drug regulation, this post is for you! Please read the full article here: [Understanding ICH and Its Role in Global Pharmaceutical Regulation](https://lnkd.in/dPX_yESG) Let's discuss how ICH shapes the future of pharma. Your thoughts and feedback are most welcome! 💬💡 #Pharmaceuticals #RegulatoryAffairs #ICH #DrugDevelopment #GlobalHealth #PatientSafety #PharmaRegulation