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As a PharmD student passionate about Clinical Research, Pharmacovigilance, Medical Affairs, and Regulatory Affairs. Dedicated to advancing healthcare through research, regulatory compliance, and patient safety.
Completed Course: Pharmacogenomics in Drug Safety. In a world where personalized medicine is future we have to understand critical role of genetics in drug safety. #Pharmacogenomics #DrugSafety #pharmd #gcp #genetics #CertificationComplete #PersonalizedMedicine
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FDA and Health Canada hosting virtual regional public meeting on ICH draft guidelines Prior to the next ICH Biannual Assembly meeting the FDA and Health Canada are hosting a virtual public meeting on 22February2024 from 11:00 AM to 3 PM ET. A large number of ICH guidelines that are reaching milestones are listed at the announcement website to be presented and discussed: TOPICS COVERED ICH Background ICH Guidelines Reaching or Approaching Key Milestones: -Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure Development -Q5(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin -Q9(R1) Quality Risk Management -E6(R3) Good Clinical Practice Principles and Annex 1 -M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines -E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting -M12 Drug Interaction Studies -ICH Cell and Gene Therapy Reflection Paper Q&A The full agenda and registration are available at the website: https://lnkd.in/dnzS3Mua #FDA #HealthCanada #ICHdraftguidelines
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Hello #connections Delighted to share the certificate of U.S.FDA organised the webinar on 'Joint US FDA - Health Canada ICH Public Meeting'. ABOUT THIS WEBINAR FDA and Health Canada will be co-hosting a regional public meeting to provide information to stakeholders and solicit input prior to the next ICH Biannual Assembly meeting scheduled for June 4-5, 2024. This public meeting will include presentations by FDA, Health Canada, PhRMA, and BIO experts on ICH guidelines recently reaching significant ICH milestones. Recently finalized ICH guidelines include analytical validation and analytical procedure development and viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Additional guidelines expected to be released for public consultation in coming months include post-approval safety data management: definitions and standards for expedited reporting and general principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real world data for safety assessment of Medicine This event is expected to be of broad interest to industry sponsors including innovator and generic companies. TOPICS COVERED ✅️ ICH Background ✅️ ICH Guidelines Reaching or Approaching Key Milestones ✅️ Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure. Development ✅️ Q5(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin ✅️ Q9(R1) Quality Risk Management ✅️ E6(R3) Good Clinical Practice Principles and Annex 1 ✅️ M14. General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety: Assessment of Medicines ✅️ E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting ✅️ M12 Drug Interaction Studies ✅️ ICH Cell and Gene Therapy Reflection Paper #HealthCanada #ClinicalResearch #Pharmacovigilance #ICH #RegulatoryCompliance #ContinuousLearning #PharmaceuticalRegulation #Innovation #Healthcare #Collaboration #ContinuousLearning #LinkedIn #Research
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We were privileged to attend and participate in a dynamic panel discussion at the #AGHE Annual Summit at #Davos on January 18th facilitated by Partners For Patients NGO. The focus was on "Regulating the Use of GMOs in Gene Therapy Clinical Trials – From Science and Public Perception to Law.” The Gene Therapy (GTx) sphere presents unique challenges and is rapidly evolving. Most GTx applications fall under specific regulations due to their status as Genetically Modified Organisms (GMOs). The panel delved into the intricate interplay between science and law that has shaped our current landscape and what the future might hold. Here are a few key insights from the discussion: 🔹 GTx therapies are designed as once-in-a-lifetime treatments, with patients typically shedding viral particles for a limited period post-administration. 🔹 Reform of EU Pharmaceutical Legislation aims for centralization of the GMO application and review process, streamlining the bureaucratic burden for all parties involved. 🔹 No environmentally harmful effects of medicinal GMO use have ever been observed At Acquis, we’re committed to helping our clients in navigating regulatory requirements, particularly in the ever-changing landscape of CGT. Discover how we can assist your organization in preparing for upcoming regulatory requirement changes here: https://lnkd.in/gNC766qm. #WEF24 #PharmaConsulting #RegulatoryCompliance #GeneTherapy #HealthcarePolicy #LifeSciences
Preparing Pharmaceutical Companies for Major Compliance Requirement Changes
acquisconsulting.com
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𝐀𝐌𝐄𝐒 𝐓𝐄𝐒𝐓 Today, I would like to share about the #ames Test, particularly about the basics, principle and type of #bacterial #strains that are used. In the field of genotoxicity studies, the AMES test stands as one of the primary and pivotal assessments within our industry. 𝗕𝗮𝘀𝗶𝗰𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗔𝗺𝗲𝘀 𝗧𝗲𝘀𝘁: The Ames Test, named after its ingenious inventor, Dr. Bruce Ames, is a cornerstone of genetic toxicology. It is utilized to evaluate the mutagenic potential of various substances, guiding us in ensuring the safety of our environment and consumer products. At its core, it employs bacterial strains with specific genetic mutations as test organisms. 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗶𝗻 𝗔𝗰𝘁𝗶𝗼𝗻: The Ames Test operates on the principle that mutagenic substances can induce mutations in these bacteria, leading to the formation of colonies when cultured on a minimal medium lacking essential nutrients. Key to this is the comparison with negative and positive control groups, the use of metabolic activation systems, and a quantitative assessment based on colony formation. 𝗧𝘆𝗽𝗲𝘀 𝗼𝗳 𝗦𝘁𝗿𝗮𝗶𝗻𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗔𝗺𝗲𝘀 𝗧𝗲𝘀𝘁: The diversity of bacterial strains used in the Ames Test is a vital component. These include histidine-requiring strains like Salmonella typhimurium (e.g., TA98 and TA100), auxotrophic strains, tryptophan-requiring strains (E. coli), strains with specific mutations for frame-shift and base-pair substitution detection, and those used in conjunction with S9 metabolic activation. Each of these strains serves a unique purpose in detecting a wide spectrum of mutagenic potential, from base-pair substitutions to frame-shift mutations, and substances that require metabolic activation. The Ames Test has stood the test of time as a gold standard for safety assessment, enabling regulatory agencies to make informed decisions about chemicals, pharmaceuticals, and consumer products. For genotoxicity studies, AMES test is one of the few major tests our industry currently possesses. #AmesTest #toxicology #genotoxicity
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🗓️ Mark Your Calendar: A joint US FDA – Health Canada ICH Webinar will be held on February 22, 2024 11:30 AM – 3 PM EST ✅ The FDA and Health Canada will be co-hosting a regional public meeting to provide information to stakeholders and solicit input prior to the next ICH Biannual Assembly meeting scheduled for June 4-5, 2024. Topics Include: • ICH Background • ICH Guidelines Reaching or Approaching Key Milestones o Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure Development o Q5(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin o Q9(R1) Quality Risk Management o E6(R3) Good Clinical Practice Principles and Annex 1 o M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines o E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting o M12 Drug Interaction Studies • ICH Cell and Gene Therapy Reflection Paper • Q&A To register for the webinar: https://lnkd.in/gJajAdH4 #FDA #MHRA #HealthCanada #clinicalresearch #regulatorycompliance #Pharmacovigilance #Healthcare #Innovation #DrugSafety #medassessment
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