Vertex Pharmaceuticals的动态

Thrilled to have attended the webinar on 'Career Opportunities & Scope of Drug Regulatory Affairs' organized by Curio Training & Research Institute (CTRI) & CliMed Academy (CliMed.Edu) academy, initiatives of CliMed Research Solutions Research Solutions, on September 15, 2024. Grateful for the valuable insights into the dynamic field of drug regulatory affairs and its vast career potential. #DrugRegulatoryAffairs #CareerDevelopment #PharmaceuticalIndustry"

Elevating Clinical Trials & Drug Development Staffing Solutions in 2025: "Flexibility, Expertise, Growth" Happy New Year - 2025 #Clinicalstaffing #Clinicalresources #FSP #Contractualstaffing #Permanentstaffing #Drugdiscovery

Hello Everyone, Please share your resume to [email protected] Global Regulatory Strategist Remote Overview: ? Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. ? Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities. ? Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions. ? Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed. ? Provide strategic direction (and content input) on US Labelling. ? Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result. Apply here: https://lnkd.in/eWJK6cuG Katalyst HealthCares & Life Sciences Regulatory Affairs Professionals Society (RAPS) #Regulatory #IND #NDA #Strategy

Ready to launch your IND application? Success starts with preparation ?? Key elements for a smooth IND submission: ??. ???????????? ?????????????????????? ???????? ?????????????? - Complete safety studies - Robust pharmacology results - Well-documented manufacturing process ??. ?????????? ???????????????? ???????????????? - Detailed study design - Patient safety measures - Specific endpoints ??. ???????????????????? ???????????????????? - FDA guidelines alignment - Quality control systems - Documentation standards ??. ???????????? ???????? ???????????????? - Regulatory specialists - Clinical researchers - Manufacturing experts ? Learn these elements, and your IND application will stand out. The path to approval becomes clearer when you focus on quality and thoroughness ?? Your innovative treatment is one submission away from helping patients. ------------------------------------ ??Repost to help your Network ??Follow Olivier Freytag for more

?? ?? Excited to Share a Milestone in My Regulatory Affairs Journey! ?? ?? I’m thrilled to announce that I’ve successfully completed the ORAQ Regulatory Affairs Training Program at Duke University School of Medicine University! ?? This incredible program provided in-depth knowledge on regulatory processes for drugs, biologics, and medical devices—a huge step forward in my professional growth. ? Key Takeaways ? ? Thorough understanding of the IND application process, preclinical/clinical study requirements, and FDA communication strategies. ? Insights into 510(k) submissions, substantial equivalence evaluations, and IDE preparation, submission, and maintenance. ? Explored regulatory pathways for low-risk devices and cutting-edge solutions like mobile medical applications. ? Preparing and managing Investigational Device Exemptions (IDE) . ?Effective strategies for FDA communication during drug development. This program has refined my skills, strengthened my passion for patient safety, and fueled my excitement for advancing medical innovations! I look forward to applying these enhanced skills in clinical trials, quality assurance, and regulatory strategy for pharmaceuticals and medical devices. Let’s connect to discuss regulatory affairs, share insights, or explore collaboration opportunities! ?? #RegulatoryAffairs #ORAQTraining #DukeUniversity #DrugDevelopment #MedicalDevices #FDARegulations #ClinicalResearch #PatientSafety #Innovation #MedicalTechnology #ProfessionalGrowth #Healthcare ????

?? Excited to Share a Milestone in My Regulatory Affairs Journey! ?? I recently completed the ORAQ Regulatory Affairs Training Program by Duke University, a comprehensive course that provided in-depth knowledge about regulatory processes for drugs, biologics, and medical devices. Through this program, I gained valuable insights into: ? The drug development process, including Investigational New Drug (IND) applications and preclinical/clinical studies. ? Best practices for communication with the FDA during drug development. ? 510(k) submissions and substantial equivalence evaluations for medical devices. ? Preparing, submitting, and maintaining Investigational Device Exemptions (IDE). ? Regulatory pathways for low-risk devices and mobile medical applications. Each week offered hands-on learning with case studies, lectures, and quizzes that deepened my understanding of FDA regulatory guidelines and frameworks. This experience has enhanced my skills in navigating complex regulatory landscapes and reinforced my passion for ensuring patient safety and advancing medical innovations. I’m looking forward to applying these skills as I continue my journey in regulatory affairs, particularly in areas like clinical trials, quality assurance, and regulatory strategy for medical devices and pharmaceuticals. ?? Let’s connect if you’re interested in discussing regulatory affairs or exploring collaboration opportunities! #RegulatoryAffairs #ORAQTraining #DukeUniversity #DrugDevelopment #MedicalDevices #FDARegulations #ClinicalResearch

???????? ?????????????????? ???????? - ???????? ???????????????? Excited to have finalised travel plans for my upcoming visit in the New Year for JP Morgan, and visiting clients to discuss their exciting growth plans for 2025. Setting up meetings for hiring managers across any of our key disciplines: ??Clinical Development ??Regulatory Affairs ??Quality Assurance - GCP & GMP ??Clinical Research - Phase I-IV ??Medical Affairs - Publications, Training, Launch Excellence ??Legal & Finance Alongside these meetings I will be in a position to discuss our strategic partnerships with three of our consulting partners: Galanthus Scientific Group - A medical communications agency built on experience, innovation and partnership. An agency providing a blend of traditional and leading-edge services. Evimed - Providing consultancy services to the pharmaceutical industry, focussing on technical excellence in evidence synthesis, health economics and outcomes research, real world evidence, and pricing. Niche Science & Technology Ltd - Team consists of specialists in regulatory writing, scientific communications and clinical project management. #JPM2025 #Sanfrancisco #biotech #pharmaceutical #FDA #FDAapproval #qualityassurance #regulatoryaffairs #clinicalresearch #medicalaffairs #generalcounsel #legalcounsel

I'm excited to share that I have completed the Course in Drug Regulatory Affairs It was an incredible experience of learning. Furthermore, regulatory affairs professionals,it play a crucial role in the post-approval phase of clinical research. It is responsible for submitting regulatory filings and maintaining compliance with regulatory requirements throughout the lifecycle of a product. looking forward to applying this knowledge to contribute to drug affairs. #Gainingknowledge #learner #Drug #Professional Devlopment #udemy Certificate Course in Drug Regulatory Affairs (DRA) @Dr. Sachin potawale (Instructor)

?? Exciting News in Drug Interaction Studies! On August 2, the FDA issued the final guidance on M12 Drug Interaction Studies, setting new standards and expectations for industry practices. This crucial update is designed to streamline drug interaction studies and enhance the clarity and reliability of the data we all depend on. ?? Why It Matters: The guidance provides detailed recommendations on study design, data interpretation, and reporting for drug-drug interactions. Adhering to these guidelines is essential for ensuring that new medications are safe and effective, and for navigating the regulatory landscape smoothly. ?? How We Can Help: Navigating these new guidelines can be complex. At Grand Strand Clinical Trial Services, we specialize in delivering high-quality medical writing services tailored to the latest regulatory requirements. Our team of experts is well-versed in the nuances of the M12 guidance and is here to support you every step of the way. ? Our Services Include: - Comprehensive regulatory document preparation - In-depth analysis and reporting - Expert guidance on study design and execution - Tailored solutions to ensure compliance and streamline submissions Let us help you stay ahead of the curve and ensure your drug interaction studies meet the latest standards with precision and clarity. Reach out to us to learn more! ?? #druginteractionstudies #FDAGuidance #medicalwriting #IndustryUpdate #Biotech #Pharma #GSClinical #GSCTS