Join us to hear from Dr. Colleen Kuemmel, former FDA writer in the Office of Clinical Pharmacology, about her writing journey from crafting documents for submission to FDA to drafting agency policy documents. Date: March 9th Time: 12:00 noon-1:00pm PT Location: Zoom Registration: free for...
A Practical, Resource Effective Approach to Risk Management: Common and Customized Tools 1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Manuel Pestana da Silva, QRM Specialist, 4TE – A ValGenesis Company Moderators: Tommi Papson, OCRA Past President During this presentation we are joined by Manuel...
OECD Data Integrity US and International Compliance 1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West) at the US Food and Drug Administration, Greater Chicago Area Moderators: Allison Oliva, OCRA Professional Liaison During this presentation, Director Pittman will review...
FDA Operations Update: Topics following the execution of the 2020 Resiliency Roadmap for FDA Inspectional Oversight plan. Remote Regulatory Assessments: Insight into how to manage electronic-based FDA inspections and assessments of medical device quality systems, with the continued use of RRA. 1 CE Contact...
1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Neelu Gibson Moderators: Allison Oliva, OCRA Professional Liaison Synopsis: Change is the only Constant - Leading through Uncertainty The many events of the last two plus years have necessitated employees, business functions and regulators to think and...
Live Webinar: PARALLEL SCIENTIFIC ADVICE: FDA EMA PARALLEL SCIENTIFIC ADVICE (PSA) PROGRAM San Diego Regulatory Affairs Network July 2022 Program SPEAKER: Valmik Doshi, MS Senior Manager, Regulatory Affairs Strategy OCRA members will be able to register for this event as SDRAN members. Register here:...
1.5 CE Contact Hour Location: ZOOM Webinar Speakers: Nancy Singer, JD, LLM, RAC, FRAPS; John Yezeski, Co-Founder, Blue Note Interactive Moderators: Allison Oliva, OCRA Professional Liaison; Courtney Boudreaux, OCRA Social Media Chair Synopsis: Documents are like diamonds. They are very precious. And they last forever....
-- -- Questions? Contact program@ocra-online.org OCRA’s non-profit Federal Tax ID# 33-0630455 The name used on registration will be used on the certificate
OCRA & SDRAN Educational Programs present "A Perspective on Combination Products" by John (Barr) Weiner, Associate Director, FDA Office of Combination Products, Steven Hertz, FDA Office of Pharmaceutical Quality (Pending) and Nazia Rahman Policy Analyst, CDRH and “The Regulatory Transformation of Human...
Do you have a novel biotech idea but need help bringing it to market? What regulations may impact your product development? How much money will you need and where to raise it? Which ideas investors fund and why? And finally, how do you convince healthcare providers and patients to use your invention? OCRA has partnered with the Small Business Development Center (SBDC)@UCI Beall Applied Innovation to present a Business of Healthcare event. Local entrepreneurs, investors, marketing strategy experts will share their valuable knowledge and real-life experiences in what it takes to turn an idea into a successful venture. Understand the correlation between risk management, clinical evaluation, and other post market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations
As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closely on multi-product IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid.
Emerging Technologies and Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management.
U.S. Food and Drug Administration granted Dexcom a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The purpose of this presentation is to share best practices around expanding an indication to include pediatrics. Coupled with providing a simple and effective ecosystem for parents & caregivers meant improved diabetes management for children and reduced finger sticks. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.
FDA’s Bioresearch Monitoring (BIMO) Program is a comprehensive system of on-site inspections and data audits designed to monitor all aspects of FDA regulated research; with complicance activities across all 6 of FDA's Centers (CBER, CDER, CDRH, CFSAN, CTP, CVM). BiMo West includes a territory extending from Chicago to Hawaii. This dedicated divison staff conducted over 100 inspections in 2020 alone, including many facilities and laboratories manufacturing new Covid 19 treatments and test kits. Join the expert BiMo West staff and learn about their mission and some of their real life findings in “Tales from the BiMo Files”
Risk-based monitoring including remote monitoring, is an approach that has been successfully applied now for many years. With increased requirements for conducting post-market clinical follow-up studies and registries, how can monitoring be optimized so you continue to ensure compliance and accuracy of data that will be accepted by the notified bodies or regulators while keeping costs reasonable? Risk-based remote monitoring combined or not with onsite activities and a strong risk management structure, along with well-designed compliant tools can make the whole process much faster and reduce the amount of financial and human resources needed.
Clinical Evidence Reports (CERs) represent a key component to technical files, registration, and compliance in many countries. CERs are meant to provide a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use. All of the supporting clinical evidence should be closely reviewed through a systematic critical appraisal process. The transition to MDR and IVDR in Europe has accelerated the need for up-to-date Clinical Evaluation Reports (CERs) that pass muster with multiple requirements including MedDEv 2.7/1 REV. This applies to every medical device sold in Europe irrespective of the risk classification and experience in the market. In the presentation, we will cover the nuances to meet requirements for the major countries/regions: including Europe’s Notified Bodies, Australia’s TGA, China’s NMPA, Brazil’s ANVISA, and Canada’s Health Canada. We will share about best practices and lessons learned for each of these regulatory reviews. We will also cover the new post-market surveillance requirements required by MDR that affect the CER.
Our days of weekly travel and on-site visits to provide hands-on product training, study monitoring and case support may be gone forever! If you want to learn how to plan for the future of virtual clinical studies, join FDA BIMO West Director Eric Pittman, for his presentation on “Decentralized Clinical Trials - What Sponsors and Investigators need to know for successful virtual study planning and execution.” Learn about FDA’s best practices and guidances for hybrid study design; consent options, remote patient visit and monitoring methodologies, data collection and transfer privacy concerns.
OCRA is hosting another Virtual Networking, to help connect fellow OCRA members! Join us on Wednesday, April 21st at 5:30 pm via ZOOM. Come prepared to introduce yourself & network. There will also be a FUN interactive activity to help everyone get to know more about each other!
Invite Others To Join as well!
While this event is FREE, we are asking for all attendees to visit our website to update their information and check on their membership status.
Brexit is now over and as of January 1, 2021, medical device manufacturers are officially in a transition period until June 30, 2023. However, you must understand the current requirements for UK MHRA registration, obtaining the services of a new UK Approved Body, and working toward affixing the new UK CA or UK NI mark on medical devices entering Great Britain. Further, UK MHRA will not be utilizing the EU MDR or EU IVDR after the transition period but drafting brand new legislation for their new Medical Device/IVD approval scheme. While everyone is focused on the EU – do not forget the Great Britain market and these new requirements.
A Hands-On To-Do Shortlist of Regulatory Action to be taken in 2021. Webinar 1.5 Hours Towards Your Continuing Education Program Manager: Piet Lesage, Principal Consultant GB5D Speakers: Jaap Laufer MD, PharmD, Medical Director at Emergo by UL. Ronald Baumans, Senior Consultant, Regulatory Affairs, Emergo...
