dia pharmacovigilance 2023
DIA Learning provides safety and pharmacovigilance professionals with the knowledge needed, from regulations and requirements, to pre-market and post-market monitoring, to stay afloat in the ever-changing world of healthcare. Insuvia. Planning a Trial with Safety in Mind Aggregate Safety Assessment Plan Obstacles and Opportunities, Short Course: Aggregate Safety Assessment Planning, Short Course: Good Pharmacovigilance Practice (GVP) Operations Development - From Clinical Trial to Post Marketing, Short Course: Pharmacovigilance and Risk Management Planning, Global Pharmacovigilance and Risk Management Strategies Conference Resource Kit, Download and fill out our Justification Letter. What are Pharmacovigilance basics? This includes recording, analysis, and evaluation of suspected adverse drug reactions (ADRs), with the aim of detecting and preventing harm to patients. With a first degree in Biochemistry & Pharmacology and a PhD focussing on drug metabolism and Pharmacokinetics Graeme has worked in the areas of Drug Safety and Medical services for nearly the last 30 years.<br>Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 19 years for PharSafer. Purchasing training for a group? Global Pharmacovigilance and Risk Management Strategies Conference Stay current with the latest safety regulations from global health authorities and regulatory experts! The forward-thinking sessions will address the complexities of operating in a global environment and how to apply new technologies and methods for streamlining pharmacovigilance systems and processes. This website uses cookies. New perspectives are explored. Coordinated and implemented Real-World-Data (database) studies. jul. ), virtual audits and inspections and global collaboration in safety monitoring and assessment. Anyone curious/interested, established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance. DIA 2023 Global Annual Meeting June 25-29, 2023 Real-World Evidence Conference October 16-17, 2023 Canada Annual Meeting November 13-14, 2023 Global Pharmacovigilance and Risk Management Strategies Conference February 05-07, 2024 Explore Event Catalog Live Virtual Events Eliminate Travel Expenses and Exhaustion The Certificate Program is designed for individuals new to the field with one to three years of experience, or for those looking to broaden their expertise in this area. These competencies outline the functional knowledge and skills needed to work in safety and pharmacovigilance and comply with US and EU regulations. January 11, 2023. Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA! Nov 29, 2022. Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events. NEXT EVENT: Head of Vigilance Operations, Safety & Surveillance, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom. Not a member? Therapeutic Innovation & Regulatory Science Journal, Module 2: Drug Safety Regulatory Requirements, Module 3: Pre-Marketing Clinical Trial Safety, Module 4: Post-Marketing Safety Management, Module 5: Basics of Signal Detection and Pharmacoepidemiology, Module 7: Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies, Pharmacovigilance Quality Management System, EudraVigilance Data Analysis System (EVDAS): Practical Approach on Use for Signal Management in the EU, Global Pharmacovigilance System Master File, Diversity, Equity, and Inclusion Statement, Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS), Types and Scope of Audits and Inspections. At DIA events, key stakeholders from multiple disciplines come together to share information and insights. DIAs Safety and Pharmacovigilance Certificate Program is a comprehensive program based on the DIA Safety and Pharmacovigilance Competency Framework developed with experts working in the field. To be eligible, users must meet all of the following requirements: This worldwide summit of PDDS 2023 pledges to retain its five-year legacy of combining collaboration with access to cutting-edge scientific information, recent trends and innovations in the field of Pharmaceutics and drug delivery, along with committed support from a top-notch speaking faculty. Continuing education credits are offered for all modules. EVENT European Pharmacovigilance Congress 2022 | Milan, IT, +44 (0)1483 307920 This website uses cookies. The Research Quality Association (RQA), Nov 9-11, 2022 November 3, 2022. jan. de 2023 - o momento3 meses. - Collaborate in implementing and within the management of BIAL Group pharmacovigilance and drug safety system during clinical development, post authorization and commercialization phases, in compliance with the applicable legislation; - Collaborate in the establishment of a Pharmacovigilance network . Click accept cookies to continue. Forward-thinking sessions address the application of new technologies and methods to streamline pharmacovigilance systems and processes to enhance protection of patient safety as products become more complex, new data sources drive new analytical techniques, regulatory requirements become more detailed, and medical product development becomes more global. This virtual live training course covers essential concepts and guidance about the Global Pharmacovigilance System Master File (PSMF). I've had the pleasure of sharing this session with amazing people Lesley Maloney, Jason Cross, and Erika Diago Mariana Ramrez Telles LinkedIn: Thanks, DIA, for the invitation to LAAM 2023. Suite 310 Or you can disable cookies, but it will affect your experience. Participants will learn how to prepare for an audit and inspection in order to achieve best practices from the moment of facing the auditing/inspection visit notification to the moment of receiving the report and its conclusions. Sessions in Clinical Safety and Pharmacovigilance. This DIA/MEB face-to-face training course is designed to provide a strong foundation in all key aspects of European Post-Marketing Safety regulatory requirements. Short Course: February 5, 2023 | In-Person, Conference: February 6-8, 2023 | In-Person. Topics related to bioethical issues in clinical safety and pharmacovigilance are also welcome and may be considered for a special track in the meeting. FHC Group. Bethesda North Marriott Hotel and Conference Center, Back to Global-Pharmacovigilance-and-Risk-Management-Strategies-Conference, Clinical Associate, Pediatric Infectious Diseases, Vice President and Head, Global Risk Management & International Patient Safety, Executive Director, Medical & Drug Safety, Safety Evaluator, Division of Pharmacovigilance, OSE, CDER, Chief Scientific Officer and Senior Vice President, Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER, Associate Director of Executive Operations/Outreach and Communications, OSE,CDER, Therapeutic Innovation & Regulatory Science Journal, Global Pharmacovigilance and Risk Management Strategies Conference, Diversity, Equity, and Inclusion Statement, Benefit-risk Assessment and Communication, Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials, Discuss safety regulatory updates in the U.S, U.K, Europe, Japan, and China, Recognize MHRAs progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities, Define FDA draft guidance on the Benefit-Risk Assessment for New Drug and Biological Products for Industry, Identify new signal detection tools and reinforce the FMQ method and analysis, Evaluate how regulatory differences impact global risk management organizations and design/implementation of risk minimization materials, Describe challenges to establishing global approaches to risk minimization and identify risk analysis approaches to developing risk minimization materials, Analyze recent advances in the use of AI/ML with respect to safety surveillance, Identify the latest strategies for managing literature requirements at local and global level, Examine various ways RWE/RWD are utilized in regulatory interactions during clinical development and its role in the evaluation of safety signals arising from clinical trial data, Explain safety updates and challenges in special population including pregnancy and lactation and transgender population, Discuss challenges with reaching the minority population and barriers for enrollment in clinical trials and recognize the need for a more inclusive approach within the drug development lifecycle, Identify potential approaches to address safety challenges in cell and gene therapy and rare disease, Recognize key concerns smaller companies have encountered with the FDA Final Rule and discuss FDAs perspective regarding the concerns of smaller pharma companies. Learning Certificate Program Wrote study reports and manuscripts. Regional Patient Safety & Pharmacovigilance Coordinator . Already a DIA Member? Founded in 1964, DIA (Drug Information Association) is an international, nonprofit, multidisciplinary association that fosters innovation for improved health and well-being worldwide. DIA/MEB Excellence in Pharmacovigilance: GVP Modules I to XVI This DIA/MEB face-to-face training course is designed to provide a strong foundation in all key aspects of European Post-Marketing Safety regulatory requirements. For more information about our privacy policy and your privacy rights, please visit our websites data policy section. Feb 21, 2023 9:00 AM - Feb 24, 2023 1:30 PM. Jos Ortiz will be participating as a trainer together with Wendy Huisman in the Pharmacovigilance Quality Management System course organized by DIA. jul. Empowering patients, physicians, drug manufacturers & consumers to make the best drug safety decisions. Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA! New initiatives, and emerging regulatory requirements and expectations regarding drug safety-related policies, processes and best practices, and quality metrics, especially those relating to patient engagement; data privacy; Good Pharmacovigilance Practices (GVPs), including insights into revised modules; pre- and post-market safety; expansion of ICH (International Council for Harmonisation) E2 guidelines to developing markets; benefit-risk assessment and management; epidemiologic studies and impact on labeling; safety considerations for combination products, medical devices, generic products (including biosimilars), and advanced therapies; companion diagnostics; pharmacovigilance audits/inspections; use of digital technology for risk identification, minimization, and communication; patient-centric labeling and risk minimization methods; application of artificial intelligence to pharmacovigilance; generating meaningful insights on medical product safety from social media and other new data sources; optimizing the global pharmacovigilance footprint (including local safety offices and partners); and considerations for signal detection and management across the product lifecycle. Portugal. By clicking SUBSCRIBE, you are agreeing to our. Learn more. Or you can disable cookies, but it will affect your experience. This track provides an overview of the global regulatory environment for vigilance for medicinal products and medical devices. The pharmacovigilance plan for COVID-19 vaccines sets out how EMA and the national competent authorities in the EU Member States identify and evaluate any new information that arises promptly, including any safety signals that are relevant for the benefit-risk balance of these vaccines: Pharmacovigilance plan for COVID-19 vaccines Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events. Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA! Pharmacovigilance; DIA Europe 2023 will be held in Basel on 22-24 March 2023. First time here? Join. Explore the benefits of becoming a member. The Research Quality Association (RQA), Nov 9-11, 2022 November 3, 2022. Leadership and Governance. A framework developed by the Aggregate Safety Assessment Planning (ASAP) task force of the DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group will be discussed; including identification of safety topics of interest and the use of preferred term groupings such as the recently issued FDA Medical Queries. Career-enhancing relationships are nurtured. Pharmacovigilance Quality Management System. Through clinical safety and pharmacovigilance programs and initiatives, DIA serves as a neutral platform for all pharmacovigilance stakeholders, a safe harbor to collaborate on shared challenges and opportunities for improvement and disseminate outcomes through DIA regional and global communities. This website uses cookies. We will continue to update our practices to ensure they are current at the time of each event and will share our plans with you as we continue to prepare for each meeting. Nov 29, 2022. New perspectives are explored. DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. Early Bird Rate for DIA Industry Members until 21 August 2023! Your personal data will be processed for purpose of facilitating your request and may be used for sending you additional marketing and business development-related information about PrimeVigilance, its affiliates and our services. System course organized by DIA and your privacy rights, please visit our websites data policy.... Websites data policy section to work in safety and Pharmacovigilance and Risk Management Strategies Conference Stay current the. And inspections and global collaboration in safety monitoring and assessment inspections and global collaboration in safety monitoring assessment... Outline the functional knowledge and skills needed to work in safety and Pharmacovigilance also! You can disable cookies, but it will affect your experience Vigilance,. And insights 9-11, 2022 November 3, 2022. jan. de 2023 - o momento3 meses opportunity! Research Quality Association ( RQA ), Nov 9-11, 2022 November 3, 2022. jan. de 2023 - momento3.: Head of Vigilance Operations, safety & Surveillance, Medicines and Healthcare Products regulatory Agency ( )! By clicking SUBSCRIBE, you are agreeing to our this website uses cookies in Basel on 22-24 2023... Head of Vigilance Operations, safety & Surveillance, Medicines and Healthcare Products regulatory Agency ( MHRA ), audits... 21, 2023 | In-Person, Conference: February 6-8, 2023 | In-Person o momento3.... 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