Speaker Biographies. DRM | OSE, Gita Toyserkani Join this exceptional event in its new format from the comfort of your home or office anywhere in the world! Office of Prescription Drug Promotion (OPDP) CDER, Requirement for Electronic Submission of an Application and Study Data, Jonathan Resnick Director Division of Post-Marketing Activities 1 Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ) | CDER, Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs, Ramesh Raghavachari, Chief Associate Director Virtual ISPOR-FDA Summit 2020 September 29, 2020 . Office of Regulatory Affairs (ORA). Manufacturers and regulary affairs professionals seeking to enhance their knowledge about the FDA Quality System (21 CFR 820) and applicable subsystems. 4th FDA/PQRI Conference on Advancing Product Quality: Patient-Centric Product Design, Drug Development, and Manufacturing. Team Leader DRM | OSE, Considerations for REMS Surveys and Assessments: Planning and Reporting, Doris Auth EXPO; Agenda; SPEAKERS; Toolkit; CONTACT; FAQs; Purchase On-Demand; Learning Tracks. Updated versions will be linked here as they become available. These activities help facilitate communication with all of CTP’s stakeholders. The conference lasts two days each year, with invited sessions co-chaired by statisticians from industry, academia, and the FDA. Dates Feb 10, 2020 11:00 AM – Feb 12, 2020 2:15 PM Location Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 Team Leader Ends December 31st, 2019. Exports Certificates and Compliance Team Imports Exports Compliance Branch Division of Global Drug Distribution and Policy ODSIR | OC | CDER, Renu Lal, LCDR, USPHS Letter from the Conference Chair. The agenda is subject to change. Trump to Hold News Conference to Discuss FDA, Coronavirus. Office of Medical Policy Initiatives | CDERSoma Kalb, Director By Grace Segers December 13, 2020 / 7:11 AM / CBS News During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. If you missed the conference, you can still purchase … By. See more Share this: Click to share on Facebook (Opens in new window) Click to share … Branch I Division of Post-Marketing Activities I OLDP | OPQ | CDER, Post-approval Considerations for Changes to Manufacturing Process and Facilities, Rose Xu, Quality Assessment Lead (Acting) FDA/Xavier PharmaLink Conference 2020. FDLI’s 2020 Annual Conference Goes Virtual! April 15 & 16, 2020. consultants focused on medication errors, REMS, Human factors engineering, and adverse events; healthcare professionals specializing in medication errors, REMS, Human factors and adverse events; and. 0. This Conference: has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. The 2020 PDA/FDA Joint Regulatory Conference will be presented in a completely digital format. More information to come. Continuing Education Credit. 2019 & 2020 Participation by Occupation. The conference will take place from March 8-11, 2021. Team Leader DRM | OSE, Suranjan De Deputy Director Webinar – 23 avril 2020 Le FDA vous propose pour son prochain webinar d’aborder les sujets suivants : Le Coronavirus, l’assurance et le droit : épisode 3 – Pierre-Grégoire Marly, Professeur de droit, Président du FDA L’incidence de la crise Lire la suite… Due to social distancing and large group gathering restrictions, ACI’s FDA Boot Camp Boston changed its format from an in-person event to a live and interactive virtual conference. Regulatory Education for Industry (REdI): Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies - 06/09/2020 - 06/10/2020 News & Events for Human Drugs Webcast Before sharing sensitive information, make sure you're on a federal government site. The .gov means it’s official.Federal government websites often end in .gov or .mil. PDA Strategic Plan 2020-2026. Project Management Staff Division of Regulatory Operations for Specialty Medicine Office of Regulatory Operations (ORO) | OND, So, Your NDA Was Approved – Now What?! Attend the conference from anywhere in the world from the comfort of your computer. The training will include regulatory approaches to prevent medication errors, and the application of regulations and guidances to design labels and labeling to prevent medication errors. Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn held a news conference to announce the emergency use authorization of the Pfizer COVID-19 vaccine. The US Food and Drug Administration is scheduled to hold a press conference on the first Covid-19 vaccine authorization at 9 a.m. FDA Meetings, Conferences and Workshops Public meetings involving the Food and Drug Administration: Upcoming events, past meetings, meeting materials, and transcripts Officer until the 2021 FSA Training Conference in Atlanta! Post-approval Responsibilities and Obligations, Lawrence Allan, Regulatory Health Project Manager This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products. Division of Medication Error Prevention and Analysis (DMEPA) OMEPRM | OSE, Preventing Medication Errors: Designing User Interfaces to Prevent Medication Errors, Lolita White After much consideration and discussion, AdvaMed has made the decision to cancel the 13 th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference scheduled for April 23-24, 2020 at the Washington, DC Marriott at Metro Center.. Our team, like many of you, has been eagerly anticipating and preparing for this year’s meeting. The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. 2017 Clinical and Scientific Conference Attendees Early Bird Pricing Here! Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. On-Demand Virtual Conference. MedDRA Coordinator SBIA | DDI | OCOMM, Post-Approval Submission of Promotional Materials to the OPDP, Robert Nguyen, Regulatory Review Officer Cloud Collaboration Capability Team DDMSS | OBI | OSP, Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA, Hasmukh B. Patel If you need specific information about sponsor, sessions or courses, please reach out … Devices Track: A core theme of this program is to consider the role of risk, and risk-benefit into regulatory decisions to help advance the development of safe and effective medical devices. Deputy Director Senior Program Manager 13th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference - April 23-2 4, 2020 POSTPONED: Public Workshop - Towards Good Simulation Practices in … Dr. Hahn Keynotes The Virtual MedTech Conference in Fireside Chat with Scott Whitaker WASHINGTON, D.C. – In a wide-ranging interview for The Virtual MedTech Conference this week, FDA Commissioner Dr. Stephen Hahn spoke with AdvaMed President and CEO Scott Whitaker on the importance of Americans’ continued confidence in the integrity of the agency’s science-based product review process. 2 months ago. Downtown, Washington, D.C. Booth: #26 The Parenteral Drug Association (PDA) and the U.S. FDA are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, now in its 28th year. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Publié par Administrateur du site FDA le 12 mars 2020 12 mars 2020 Le Forum du droit des assurances (FDA) et l’International construction club (ICC), sont partenaires de l’Institut des assurances de Paris-Sorbonne concernant la conférence du 12 mars 2020 sur le … LCDR | USPHS Epidemiologist RSS | OSEMonica Muñoz Director Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. 0. This program also uses examples and specific case studies to provide a hands-on experience to reinforce the regulatory principles described. Dictionary: OHCE is tracking the number of public engagement activities CTP staff participate in quarterly. October 8, 2020. Falls Church, VA (PRWEB) November 09, 2020 -- 15th Annual FDA Inspections vSummitAn FDAnews Virtual SummitTuesday, Nov. 17-Wednesday, Nov. 18, More Meetings, FDA, DOJ Officials Talk Cannabis and CBD at Food and Drug Conference. Division of Clinical Evaluation and Analysis 1: Clinical Science and Quality Office of Clinical Evaluation and Analysis Office of Product Evaluation and Quality Center for Devices and Radiological Health (CDRH), Restructure of the Office of New Drugs (OND), Judit Milstein, Chief Office of Surveillance and Epidemiology (OSE) | CDER, Emily Thakur, Team Leader The current version is version 9, updated on April 4, 2020. Policies agreed by ADC determine the work of the FDA for the following year, giving delegates a direct influence on the priorities of the union and how it can improve the working lives of members. Global manufacturers who are seeking to harmonize their manufacturing activities to comply with multiple country regulatory bodies. FDA/Xavier MedCon Conference Moving forward in the pandemic and beyond. Drug Shortage Staff CDER, Enhanced Drug Distribution Security – DSCSA Implementation Updates, Connie Jung, CAPT, USPHS Senior Advisor for Policy Co-founder of Cannabis Wire. Presentations include Q&A sessions. Office of Medication Error Prevention and Risk Management (OMEPRM) | OSE, Best Practices for Proprietary Name(PN) Design, Danielle Harris Watch the webcast of the event here Download a PDF of the summit presentations here Download the summit transcript here. Workshops, Regulatory Education for Industry (REdI) Annual Conference, An official website of the United States government, Download All Slides and View CDRH Presentations, Recalls, Market Withdrawals and Safety Alerts, Regulatory Science Research and Education, Guidance, Compliance, & Regulatory Information, Regulatory Education for Industry (REdI) Annual Conference - 08/25/2020 - 08/28/2020, CDER SBIA Learn: Webinars, Conferences, Trainings, Device Advice: Comprehensive Regulatory Assistance, Division of Industry and Consumer Education, Development and preparation of submissions, Newcomers, managers, or directors in the drug or medical device industries, Medical device stakeholders who want to find online resources that explain premarket and postmarket regulatory framework for medical devices. Conference Agenda. Office of Compliance Office of Drug Security, Integrity, and Response (ODSIR) | CDER, William Jones, Technical Information Specialist Manufacturers and researchers who are responsible for ensuring the cybersecurity of their medical devices. Dear Colleagues, I am pleased to invite you to the 45th International Good Manufacturing Practices Conference. Finanzierung. Date: September 16 – 18, 2019 Venue: Renaissance Washington D.C. Through presentations, conferences, public meetings, and dockets, CTP performs essential outreach and educational activities benefiting CTP and its stakeholders. PDA USA. Download our “Make the Case” document to help you justify your attendance at 2020 VISION OCRA’S FDA ANNUAL CONFERENCE. Published on Dec 9, 2020 6:55AM EST CBD. He discussed how the FDA has been responding to … The 2020 PDA/FDA Joint Regulatory Conference will be presented in a completely digital format. Team LeadManish Kalaria It can be challenging when FDA arrives for an inspection during typical circumstances. 28.09.2020. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. 2018 Clinical and Scientific Conference Attendees . 10:42 a.m. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2019, and Cases to Watch, 2020. It’s Time for You to Join Their Ranks. The … Drugs Track: This year’s agenda will complete our series of the regulatory timeline which we started in REdI 2018. DMEPA | OMEPRM | OSE, Preventing Medication Errors: Lessons Learned from Postmarket Safety Survellance, Ashleigh Lowery 2:30 p.m. - 3:30 p.m. This Conference brought together leaders from regulatory agencies, industry … The Food and Drug Law Institute is hosting officials from several federal agencies this week to discuss cannabis policies. Registration More information to come Expo FDA/Xavier MedCon Conference Moving forward in the pandemic and beyond. Conference Workshop - Virtual Sprints: May 3 & 4, 2021 Main Conference Sessions - Virtual Sprints: May 6, 10, 12 & 13, 2021 Join this exceptional event in its new format from … The site is secure. On-demand access is now available for the 9th Annual Drug Repositioning & Repurposing Conference, which took place September 21-22, 2020. Regulatory affairs professionals seeking to submit new or novel medical device regulatory submissions, including premarket notifications (510(k)s) and De Novos. The Generic Drug User Fee Amendments of 2012 (GDUFA I) established a regulatory science and research program that was subsequently reauthorized under the FDA … FDLI is excited to provide the key industry updates and the opportunity to connect with the food and drug law community that you have come to expect from the Annual Conference, just in a virtual format. Alyson Martin @alysonrmartin. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 2020 PDA/FDA Joint Regulatory Conference. Due to the on-going pandemic, this year’s meeting will be held virtually. Much of the data presented during the cannabinoids, sex and gender conference was in regard to THC’s effects on anxiety, pain, pregnancy and women’s health. Published. Division of Risk Management (DRM) | OSEShelly Harris 2021 PDA Europe Parenteral Packaging. KHZG regelt wesentliche Sachverhalte. The Annual Delegate Conference (ADC) is an annual one-day event that gives our members a unique opportunity to discuss and vote on policies for the union. The FDA is scheduled to hold a press conference on the first #COVID19 vaccine authorization on Dec. 12, 2020, at 9 a.m. EST. We will focus on “Post Approval Considerations” as we address the regulatory aspects of selected topics and utilize case studies to exemplify best practices within those areas. 21 CFR 310.305 (prescription drugs marketed for human use without an approved application); 21 CFR 314.80 (human drugs with approved NDAs); 21 CFR 314.98 (human drugs with approved ANDAs); 21 CFR 600.80 (human biological products with approved BLAs), and section 760 of the FD&C Act (nonprescription human drug products marketed without an approved application). Real-world Evidence for Drugs, Biologics, and Devices, John Concato, Deputy Director Division of Pharmaceutical Quality Operations III See the Agenda. News & Events for Human Drugs. FDAnews Announces -- 15th Annual FDA Inspections vSummit, Nov. 17-18, 2020 DMEPA | OMEPRM | OSE, Division of Risk Management: Overview of Review Activities, Cynthia LaCivita … ET. FDA/Xavier PharmaLink Conference 2020 — Xavier Health Back to All Events Staying Ahead in the 21st Century The FDA/Xavier PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA. Event Agenda. FDLI’s 2020 Annual Conference Goes Virtual! The daylong meeting, organized by FDA’s Office of Women’s Health, will include presentations on “sex differences in […] Files, Certificate & Recordings. The DIA/FDA’s Complex Generic Drug-Device Combination Products Conference will examine current knowledge and ongoing scientific research of the FDA Office of Generic Drugs (OGD) supporting evidence-based development, assessment, and approval of complex generic combination products. This conference was established in conjunction with the U.S. Food and Drug Administration in 1976 to create an annual ongoing dialogue between regulatory agencies and the pharmaceutical industry on important issues in drug compliance and quality. October 27 & 28, 2020 In the first-ever Orange Book Conference, FDA will showcase the Orange Book and provide a roadmap for the rich information it contains. Sept. 14, 2020 – Sept. 16, 2020 • Online Visit the Event Page. on. Thema: Ausgleichszahlung Budgetverhandlungen COVID-19 FDA 2020 Fixkostendegressionsabschlag KHZG Krankenhauszukunftsgesetz Mehrkostenzuschlag Mengenausgleich Mindererlösausgleich. ZIP of Day One Session … Click to view our speakers. : Tweets by FSAconf. Download our “Make the Case” document to help you justify your attendance at 2020 VISION OCRA’S FDA ANNUAL CONFERENCE. View all of the presentations in their entirety, visit our Exhibit Hall and connect with speakers and attendees. Cloud Collaboration Capability Team Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI) Office of Strategic Programs (OSP) | CDER, Heather Crandall The FDA is the only trade union dedicated to representing managers and professionals in public service. November 17, 2020. Budgetverhandlung nach dem Krankenhauszukunftsgesetz. FDA chief seeks to reassure Americans about COVID-19 vaccine: "I will absolutely" take it. Join FDA staff and industry experts to discuss these topics, as well as … This Summit will provide a forum to engage all stakeholders including patient representatives, medical … ET, December 12, 2020 FDA is "very concerned" about vaccine hesitancy, commissioner says ... 8:46 a.m. OPE | OSE, Danijela Stojanovic White House spokeswoman Kayleigh McEnany said late Saturday that Trump will hold a news conference at 6 p.m. EDT on Sunday on a “major therapeutic breakthrough” against Covid-19. Associate Director for Research and Strategic Initiatives DRM | OSE, Development of Shared System REMS and Implications of the Appropriations Act, Elaine Lippmann The 2020 DSC Direct Innovation Lab sessions are available for viewing here. Gerald Dal Pan, MD Find out about the Plan’s objectives, the development process, and download a copy today. Before sharing sensitive information, make sure you're on a federal government site. Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER, Questions and Panel Discussion – Post-approval CMC and Manufacturing, Hasmukh B. Patel, Ramesh Raghavachari and Rose Xu, Russell K. Riley, Compliance The .gov means it’s official.Federal government websites often end in .gov or .mil. This event is a collaboration between the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE). Pharmacovigilance and Risk Management Conference June 9 & 10, 2020 This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products. The document has several tips and includes a sample Justification Letter. FDA, USDA-FSIS, and CDC announced open registration for a virtual Public Meeting of the National Antimicrobial Resistance Monitoring System to be held October 13-14, 2020. Tuesday, March 17, 2020 8:30 AM 08:30 Friday, March 20, 2020 12:30 PM 12:30; Cintas Center 1624 Herald Avenue Cincinnati, OH 45207 USA; Google Calendar ICS; Staying Ahead in the 21st Century. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2019, and Cases to Watch, 2020. The Annual Delegate Conference (ADC) is an annual one-day event that gives our members a unique opportunity to discuss and vote on policies for the union. 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