US Pharmacopeia’s Post

Kudos to our Small Molecules team for their active engagement in Expert Volunteer Recruitment https://lnkd.in/eumte8Xv The work of the Small Molecules committees at USP is crucial for global public health for several reasons: 1. Developing and Revising Monographs: Small Molecules committees, such as the Small Molecules 1 Expert Committee, are tasked with developing and revising monographs for critical drug substances, including antibiotics, antivirals, and antimicrobials. These monographs ensure the quality and safety of drugs that are vital in treating various diseases worldwide [oai_citation:5,2020–2025 Chemical Medicines Monographs 1 Expert Committee Work Plan | USP](https://lnkd.in/e5UnN8zN). 2. Improving Pharmaceutical Standards: These committees work on converting older assay methods to more modern techniques like High-Performance Liquid Chromatography (HPLC), enhancing the reliability and precision of pharmaceutical testing [oai_citation:4,2020–2025 Chemical Medicines Monographs 1 Expert Committee Work Plan | USP](https://lnkd.in/e5UnN8zN). 3. Global Health Impact: The recognition and implementation of USP standards, particularly in emerging markets where these standards are most rapidly adopted, significantly impact the safety and effectiveness of medications available in these regions [oai_citation:3,2020–2025 Chemical Medicines Monographs 1 Expert Committee Work Plan | USP](https://lnkd.in/e5UnN8zN). 4. Expert Volunteer Involvement: Expert volunteers play a pivotal role in the committees, bringing diverse professional expertise to the standard-setting process, which is crucial for maintaining the high quality of USP’s drug standards. This volunteer-based approach ensures that standards are developed using the best available science and broad professional input [oai_citation:2,2020–2025 Small Molecules 5 Expert Committee Work Plan | USP](https://lnkd.in/eDn2Gh8V). 5. Collaborative Efforts: The committees collaborate with regulatory bodies like the FDA and other stakeholders to address and resolve issues related to pharmaceutical standards, which supports the ongoing improvement and relevance of USP standards in a changing global landscape [oai_citation:1,2020–2025 Small Molecules 5 Expert Committee Work Plan | USP](https://lnkd.in/eDn2Gh8V).

Are you curious about the real-world impact of KGI's Team Master's Project (TMP)? Discover how Pfizer, a global pharmaceutical leader, leveraged student innovation to drive meaningful change. Dr. Roslyn Schneider, then a Global Patient Affairs Lead at Pfizer, shares insights on collaborating with KGI, which resulted in: ◆ Creation of an orphan disease database, enhancing global medical research ◆ Development of strategies to improve inclusiveness and diversity in clinical trials ◆ Access to creative, innovative thinking from diverse student teams However, the benefits extended beyond project outcomes. Dr. Schneider highlights: ◆ Enhanced engagement with industry colleagues ◆ Contribution to developing future life sciences leaders ◆ Cost-effective access to high-value work Watch the video to hear Dr. Schneider's entire perspective on this "fabulous experience" and learn how Pfizer benefited from these TMPs: https://kgi.link/0ie #CollaborativeScience #Biotech #IndustryPartnerships #KeckGrad

The Education Phase of the Global Research Lab project for 2024 was organized by IPSF - International Pharmaceutical Students' Federation through Pharmaceutical Sciences Initiatives has ended with a Certificate of Participation. This phase focuses on teaching the fundamental principles and methodologies of scientific research such as research design, data collection methods, statistical analysis, ethical considerations, referencing styles, publication processes, conducting clinical trials in Pharmacy and postgraduate studies, and research carriers. The teaching seasons were conducted by academicians, researchers, and pharmacists from the Middle East, Europe, and America. For me, it was not only about learning the content but also getting to appreciate the importance of research as it continues to new knowledge generation, utilizes evidence-based approaches in patient care, and helps to enhance the healthcare delivery mechanism. Big thanks to Kareem Arafat and your team for putting effort into making this all happen. #ipsf #healthresearch #ipsfapro #pnghealt

Shaping the Future with Emerging Leaders! The Emerging Leaders program by ISPE is dedicated to empowering the next generation of pharmaceutical professionals. Tailored for students and young professionals, this initiative provides the tools, resources, and community needed to kick-start and advance careers in pharmaceutical engineering. From networking with industry veterans to accessing educational resources, Emerging Leaders is your stepping stone to becoming a visionary in the pharmaceutical world. Embrace the opportunity to shape the future of healthcare with ISPE. https://lnkd.in/gzt8eJtX

I had the pleasure of attending the panel hosted by EuropaBio - the European Association for Bioindustries at #BIOEurope, where we discussed European legislations, particularly General Pharmaceutical Legislation (#GPL) and its impact on life science innovations. Alongside industry leaders such as Claire Skentelbery of EuropaBio - the European Association for Bioindustries, Fabrizio Conicella of Chiesi Group, and Joao Incio, MD PhD of Biovance Capital, we examined how #GPL can foster disruptive innovations. It became evident that balanced legislation is vital for the sector to achieve its ambitious goals. Here are some key insights from the conversation: • Establishing an innovation-friendly ecosystem in Europe is crucial. • Investment locations depend on various factors related to the attractiveness of the innovation ecosystem, including the availability of a skilled workforce, academia, scientists, regulatory systems, and the ability to absorb innovation. • There is global competition for the location of innovation. A more friendly ecosystem increases the chances of attracting investments. • Innovators developing novel therapies need predictable legislation and IP. The takeaway message is to ensure that #GPL enhances the EU's strengths for a competitive global position. Thank you for the inspiring conversation. I look forward to continuing the work on building the innovation ecosystem in Europe! #EUCompetitiveness #AccessToInnovation #Innovation #Healthcare #Pharma #BioIndustry 

Sign up, and see you there! I will be part of a panel session, discussing common traps in Life Science contracting - and how to avoid them :-)

After a very successful 1st edition, the team Faculdade de Farmácia da Universidade de Lisboa is moving forward with a 2nd edition of the #InternationalMarketAccesss postgraduation course. Take a look If you are interested in learning more about market access in the Pharmaceutical industry.

We’re just two weeks away from the API Innovation Center’s 2nd annual plenary event, "A Bold Goal: Pathway to Build U.S. Drug Supply Chain Resilience," hosted at Washington University's Charles F. Knight Center in St. Louis on November 13, 2024! Join us for a gathering of stakeholders, industry leaders, and subject matter experts who are committed to strengthening the U.S. drug supply chain. We look forward to expanding on our discussions from last year's plenary event. Take a look at the key themes that our panel discussions will cover: - Designing a Sustainable, Long-Term Drug Supply Chain: Strategies for building a resilient drug supply chains. - Advanced Manufacturing Technologies for Domestic API Production: How innovative technology is shaping the future of API manufacturing. - Public-Private Partnerships and Collaboration: The importance of strengthening collaboration across sectors to build a stronger pharmaceutical industry. - Regulatory Affairs and Policy Considerations: Navigating policies to support supply chain resilience. If you haven't registered yet, there's still time! RSVP here: https://lnkd.in/e5zMhnww. We are also offering a virtual option for those who can’t make it in person. If you are traveling for our event and need to make accommodations, a hotel block has been reserved for guests of the conference at the Charles F. Knight Center. Please reach out to us at nweatherly@apicenter.org for more information on how to reserve your room as part of this hotel block. #SupplyChainResilience #PharmaceuticalManufacturing #APIInnovation #HealthSecurity #EconomicGrowth #FutureTech

FDA published CDER’s Office of New Drugs’ (OND) second annual Research Outcomes Report: https://lnkd.in/g4FCg-TW. The purpose of this report is to summarize outcomes from OND-funded regulatory science research projects for fiscal years 2022-2023 This report is a celebration of OND’s contributions to the field of regulatory science research, which helps the agency make informed, evidence-based regulatory decisions. The projects featured focused on addressing targeted questions that will have an impact on new drug approval decisions and provide ample room for the expansion of this research with broad goals that could further increase the impact of the work. Visit OND's Research Program website for more information on how to get involved: https://lnkd.in/gt5uWn47

Thrilled to share insights from Day 5 of the transformative workshop on Conduct of Preclinical Research with Ethical Practices & Bio-Medical Waste Management, hosted at Lovely Professional University from April 17 to 23, 2024! Mr.Sukriti Vishwas, Associate Professor at the School of Pharmaceutical Sciences, LPU, facilitated an enriching hands-on training session on Mendeley reference software. Participants delved into Mendeley's functionalities, honing their reference management skills to streamline their research workflow and enhance productivity. Concurrently, Dr. Navneet Khurana , Professor at the School of Pharmaceutical Sciences, LPU, led an engaging hands-on training session on Collection of different samples for preclinical research. His expertise guided participants through the nuances of sample collection techniques, ensuring precision and accuracy in research practices. #PreclinicalResearch #EthicalPractices #BioMedicalWasteManagement #LPU #Mendeley #SampleCollection #pharmacy