RAPS Quebec Local Networking Group’s Post

We are pleased to inform you about the upcoming education event titled "TOGETHER IN REGULATORY CHALLENGES, TOGETHER IN SOLUTIONS," which will focus on addressing key challenges and shortcomings in the process of essential evaluation of drug quality documentation. The education will take place at the premises of the CRA Academy in New Belgrade, Bulevar Mihajla Pupina 10E. The topics covered in the education include: • Regulatory framework and drug authorization by National Regulatory Agencies (NRA) • Harmonization of regulations with the EU • Drug licensing process • Drug lifecycle after authorization (variations, renewals) • Pharmacovigilance in the procedures of issuing/renewing/modifying drug permits • Practical workshop on completing registration/renewal permit applications The lecturers for this education will be: Milanka Šetina: Master Molecular Biologist and Physiologist - Geneticist, Specialist in Biological Drugs with extensive experience at the Agency for Drugs and Medical Devices of Serbia (ALIMS). Milanka is also an expert in assessing the quality documentation of all classes of biological drugs in procedures for issuing permits, renewing permits, modifying permits for placing drugs on the market, an expert in determining the compliance of the production of biological drugs with Good Manufacturing Practice (GMP) guidelines, and a participant in conducting inspection supervision as part of the inspection team for drugs and medical devices of the Ministry of Health of Serbia. Jelena Mitrašinović: Master of Pharmacy and Clinical Pharmacy Specialist, with an impressive 15 years of experience in the pharmaceutical industry. Mrs. Mitrašinović is also a spokesperson for the Agency for Drugs and Medical Devices of the Republic of Serbia. Her main professional field is pharmacovigilance, where she works on assessing cases of adverse reactions to drugs reported in the National Center for Pharmacovigilance by healthcare professionals, patients, and drug permit holders. Applications are open until February 20, 2024. You can submit your application through the provided link: https://lnkd.in/gdmyH3Au For additional information and inquiries, feel free to contact us by phone at +381 64 8734757 or via email at office@cro.rs. #CRA_Academy #pharmacy #pharmaceutical #Pharmacovigilance #medicalworkers #regulatory

The Critical Role of Literature Screening in Pharmacovigilance In the dynamic landscape of drug safety, staying ahead is key. Literature screening plays a pivotal role in pharmacovigilance, helping us unearth valuable information that contributes to patient safety and regulatory compliance. Uncovering Insights: Literature screening involves a thorough examination of scientific literature, journals, and databases to identify relevant information about adverse drug reactions, safety concerns, and emerging trends. This proactive approach allows us to anticipate potential risks and take timely preventive measures. Global Awareness: Adverse events can be reported from various sources. Literature screening helps us tap into a wealth of global information, ensuring a comprehensive understanding of the safety profile of pharmaceutical products across diverse populations. Data-Driven Decision Making: Literature screening empowers us to make informed decisions. This process enables the identification of signals, trends, and patterns, laying the foundation for robust risk management strategies. Collaboration and Compliance: Effective literature screening fosters collaboration among stakeholders, including regulatory bodies, healthcare professionals, and researchers. This collaborative effort ensures compliance with evolving regulatory requirements and promotes a shared commitment to patient safety. Linking Knowledge for Safer Medicines: As professionals in the pharmaceutical industry, let's continue to champion the importance of literature screening in pharmacovigilance. By linking knowledge and leveraging the collective power of data, we contribute to the development of safer and more effective medicines. Join the Conversation: What are your thoughts on the evolving landscape of literature screening in pharmacovigilance? Share your insights and experiences in the comments below. #Pharmacovigilance #DrugSafety #LiteratureScreening #PatientSafety #Pharmaceuticals #HealthcareInnovation

The Rising Tide of Pharmaceutical Regulatory Affairs: Why It's the Career of Choice in 2024 In the ever-evolving tapestry of the pharmaceutical industry, 2024 has witnessed a remarkable surge in one particular domain: Pharmaceutical Regulatory Affairs (PRA). This niche, once overshadowed by more flamboyant pharma roles, is now at the forefront of career desirability. But what sparked this seismic shift? The answer lies in the global health landscape's complexity. The pandemic years reshaped pharmaceuticals, escalating the need for adept regulatory professionals. These experts are not just gatekeepers of compliance but architects of a safer health future. They navigate the labyrinth of global regulations, ensuring drugs are both effective and safe - a role made more pivotal with the rapid pace of medical innovation. Interestingly, PRA professionals are now the linchpins in expediting life-saving drugs to market. Their expertise in navigating regulatory pathways is invaluable, especially in an era where speed is as crucial as safety. This evolution from a back-office function to a strategic role has placed PRA in the spotlight. Beyond the intrinsic appeal of the job, the profession's allure in 2024 is also due to its dynamic nature. PRA roles are constantly adapting, offering a career that is as challenging as it is rewarding. This is not a static desk job; it's a role at the frontier of medical progress. Recognizing this trend, Strategic Axis has launched what is arguably the most comprehensive course in Pharmaceutical Regulatory Affairs. Tailored for 2024's landscape, their program equips aspirants with the tools to excel in this burgeoning field. The course blends theoretical knowledge with practical insights, ensuring graduates are not just well-versed in regulations but are also strategic thinkers, ready to take on the industry's challenges. In conclusion, as the pharmaceutical industry continues to grow and evolve, the role of regulatory affairs professionals has never been more critical. Their expertise ensures the safety and efficacy of medications, contributing significantly to public health and well-being. For those looking to make a meaningful impact in the healthcare sector, a career in pharmaceutical regulatory affairs is a top choice in 2024.

Pharmacovigilance and all drug safety issues are relevant for everyone whose life is touched in any way by medical interventions. In the last years, the scope of pharmacovigilance has extended beyond the strict confines of detecting new signals of safety concerns, the rise to new kinds of safety concerns such as: illegal sale of medicines and drugs of abuse online, increasing self-medication practices, irrational and potentially unsafe drug donation practices, widespread manufacturing and sale of substandard & falsified medicines, increasing use of traditional medicines and herbal medicines with other medicine with potential for adverse interactions have led to the redefinition of the purpose of Pharmacovigilance in Healthcare. Therefore, the African Pharmaceutical Network (APN) has designed the #Pharmacovigilance and #PatientSafety course to equip healthcare professionals with basic skills and competencies required for the performance of pharmacovigilance functions in a biopharmaceutical company as well as managing relations with key regulatory agencies with regards to key pharmacovigilance principles &responsibilities. Register: https://lnkd.in/di_kGB53 Classes begin in May 2024. #WorkforceDevelopment #Pharmacovigilance

I am looking forward to join the #EuropeanPharmacovigilanceCongress 2024, where I will be sharing insights on the #Innovative and #Best #Practices of #Pharmacovigilance in Saudi Arabia. This is a great opportunity to engage with other subject matter experts and delve into the evolving landscape of pharmacovigilance across the globe. Looking forward to learning and contributing to these important discussions! #Innovation #Pharmacovigilance #PatientSafety

Join Valeria Grigoriev, MBA, our Senior Regulatory Affairs Specialist, along with presenter’s from Phortas and the Head of Scientific Advice from the #EMA.   RAPS Europe Euro Convergence   Tues May 7, 13:45 – 14:45 CEST Location: A 05 + A 06   Meeting EMA and FDA: Formal and informal pathways, in search of alignment   Why attend? • Enhance regulatory engagement: Understand how scientific advice and informal meetings can improve communication and collaboration with regulatory agencies, enabling participants to establish effective lines of communication throughout drug development. Evaluate whether alignment with EMA and FDA is an actually achievable Parallel SA (PSA) meeting goal. • Optimize development strategies: Establish suitable type of topics and questions to be raised during informal versus scientific advice meetings, as well as get the best practices for concluding an exhaustive briefing package. Learn how to tailor drug development plans based on insights gained from regulatory interactions, allowing participants to make informed decisions, mitigate risks, and expedite the development process. • Improve compliance and quality assurance: Discover best practices for maintaining compliance and ensuring high-quality standards throughout drug development by applying lessons learned from successful Scientific Advice and informal interactions with the #FDA and EMA.   A full description of the session follows:   As regulatory affairs professionals we are familiar with the official meetings offered by the regulatory authorities EMA and FDA and, their importance for adequate drug development. An example of optional meetings offered during various time points in the product life cycle to support the resolution of scientific and regulatory issues is Scientific Advice (SA). These meetings in the US are typically referred to, for example as Type, A, B or C meetings. SA is not legally binding on authorities regarding any future marketing authorization application for the medicine concerned. In this way, no pre-evaluation of the results of the studies or conclusions on benefit-risk assessments can be granted. And still, the increase in the number of scientific advice requests remains constant. Interestingly, few regulatory professionals are familiar with all types of interactions offered by both EMA and FDA. Rarely used authority interactions, namely EMA SME briefing meetings and FDA INTERACT or pre-breakthrough meetings, hold significant benefits for drug development. In this session, we will discuss the advantages and disadvantages of SA and informal meetings as well as best practices for the preparation of such meetings. A reflection from a 5-year Parallel (PSA) program review will be presented on whether alignment with EMA and FDA in a PSA meeting is an achievable goal. Besides identifying the best candidates and the most suitable development phase to apply, the most noteworthy findings will be emphasized. #regulatory #pharmaceuticals 

Join Virtue Insight's #ClinicalTrials Summit 2024! Interesting panel session on Decentralisation - Sustaining DCT adoption in a challenging economic environment with our experts DILIP PAWAR, Dr Vaibhav Salvi, Nishith Vyas, Kedar Nayak, Dr. Pravin Ghadge MD, Dr. Kamlesh Patel https://lnkd.in/gaFcSFXg For our upcoming conferences visit : https://lnkd.in/gjQY86dn #VIct #clinicalresearch #clinicaloperations #clinicaldevelopment #ClinicalResearchNews  #cro #qualitycontrol #qualityassurance #RegulatoryAffairs #RegulatoryWriting #pharmacovigilance #medicalaffairs #patientsafety #biosimilars #patientsafety #pharmaceuticalmanufacturing #pharmaceuticals #pharmaceuticalindustry #pharmanews #healthcare #medicines #lifesciences #biotech #mumbai 

The Rising Tide of Pharmaceutical Regulatory Affairs: Why It's the Career of Choice in 2024 In the ever-evolving tapestry of the pharmaceutical industry, 2024 has witnessed a remarkable surge in one particular domain: Pharmaceutical Regulatory Affairs (PRA). This niche, once overshadowed by more flamboyant pharma roles, is now at the forefront of career desirability. But what sparked this seismic shift? The answer lies in the global health landscape's complexity. The pandemic years reshaped pharmaceuticals, escalating the need for adept regulatory professionals. These experts are not just gatekeepers of compliance but architects of a safer health future. They navigate the labyrinth of global regulations, ensuring drugs are both effective and safe - a role made more pivotal with the rapid pace of medical innovation. Interestingly, PRA professionals are now the linchpins in expediting life-saving drugs to market. Their expertise in navigating regulatory pathways is invaluable, especially in an era where speed is as crucial as safety. This evolution from a back-office function to a strategic role has placed PRA in the spotlight. Beyond the intrinsic appeal of the job, the profession's allure in 2024 is also due to its dynamic nature. PRA roles are constantly adapting, offering a career that is as challenging as it is rewarding. This is not a static desk job; it's a role at the frontier of medical progress. Recognizing this trend, Strategic Axis has launched what is arguably the most comprehensive course in Pharmaceutical Regulatory Affairs. Tailored for 2024's landscape, their program equips aspirants with the tools to excel in this burgeoning field. The course blends theoretical knowledge with practical insights, ensuring graduates are not just well-versed in regulations but are also strategic thinkers, ready to take on the industry's challenges. In conclusion, as the pharmaceutical industry continues to grow and evolve, the role of regulatory affairs professionals has never been more critical. Their expertise ensures the safety and efficacy of medications, contributing significantly to public health and well-being. For those looking to make a meaningful impact in the healthcare sector, a career in pharmaceutical regulatory affairs is a top choice in 2024.

#DAY1 of #Pharmacovigilance USA 2024! It’s time to hear from our expert panellists about Quality, Safety Evaluation & Signal Detection – Important Considerations - Analise to Adapt Ben Locwin, Bill Haddock, LAURA RAY RN, Teodora Doherty, David Lilienfeld Cencora IQVIA RxLogix Corporation Qinecsa Solutions Clinexel Life Sciences Pvt Ltd Arietta.ai Vitrana For our upcoming conferences visit : https://lnkd.in/gjQY86dn #VIphv #drugsafety #drugdevelopment #ClinicalSafety #patientsafety #RiskManagement #safetysurveillance #medicinesaffairs #pvusa #clinicaltrials #usa #clinicalresearch #vigilance #clinicaldevelopment #Qualitycontrol #pharma #healthcare #lifesciences #RegulatoryAffairs #RegulatoryWriting #MedicalWriting #scientificwriting #regulatory #pharmaceuticals #biosimilars #biotech #patient