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MCRA, an IQVIA business
เข้าร่วมเมื่อ 4 มี.ค. 2021
MCRA, an IQVIA business, is the leading therapy-focused global clinical research organization (CRO) and integrated advisory firm specializing in global clinical and regulatory affairs, reimbursement and market access, quality assurance, compliance, cybersecurity, and due diligence support for the medical device industry. Our global footprint with leadership across the top 3 medical device markets: US, Europe and Japan, integrated services expertise and deep therapeutic knowledge make us the leading partner to bring medical device innovation to market.
Healthcare Compliance: A Year In Review - MCRA Webinar
Join MCRA's insightful panel discussion, "Healthcare Compliance: A Year in Review," where we delve into the evolving landscape of healthcare legal and compliance challenges over the past year. This engaging webinar features a panel of distinguished experts, each bringing their unique perspectives and experiences to the table.
The webinar is moderated and lead by MCRA’s Head of Healthcare Compliance Hassan Abdallah and include:
Reimbursement Challenges by Joe Rivet, Esq. CCS-P, CPC, CHPC, CHC, CAC | Managing Partner at Rivet Health Law PLC
In-House Counsel/Provider Group Challenges by Wedad Suleiman, J.D., LL.M., CHPC | AVP, Asst. General Counsel, Radiology Partners
Enforcement Actions by Debra Geroux, JD, CHC, CHPC | Attorney Shareholder and Co-Chair of Healthcare Law Group at Butzel Long
Value of Compliance Investment by Hassan F. Abdallah, J.D., CHC, CPCM | Head of Healthcare Compliance at MCRA, an IQVIA business
Webinar hosted by MCRA.
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MCRA, an IQVIA business, is the leading therapy focused global full-service medical device, diagnostics & biologics CRO & consulting advisory firm.
MCRA is the pioneer and leader in integrating its core service offerings to bring healthcare innovation to the market globally, from conception to commercialization.
Our team of industry leading talent, including former FDA reviewers, notified body decision makers, clinical subject matter experts, reimbursement veterans and payers, provides in-depth therapeutic knowledge and thorough market understanding to each project we take.
MCRA's Service Offerings:
Full Service Clinical Research Organization
Global Regulatory Support
US Regulatory Support
Reimbursement, Healthcare Economics & Market Access
Quality Assurance & Quality Operations
Healthcare Compliance
Cybersecurity
Due Diligence
AI & Imaging Center
Talent Solutions
Learn more about MCRA at www.mcra.com.
The webinar is moderated and lead by MCRA’s Head of Healthcare Compliance Hassan Abdallah and include:
Reimbursement Challenges by Joe Rivet, Esq. CCS-P, CPC, CHPC, CHC, CAC | Managing Partner at Rivet Health Law PLC
In-House Counsel/Provider Group Challenges by Wedad Suleiman, J.D., LL.M., CHPC | AVP, Asst. General Counsel, Radiology Partners
Enforcement Actions by Debra Geroux, JD, CHC, CHPC | Attorney Shareholder and Co-Chair of Healthcare Law Group at Butzel Long
Value of Compliance Investment by Hassan F. Abdallah, J.D., CHC, CPCM | Head of Healthcare Compliance at MCRA, an IQVIA business
Webinar hosted by MCRA.
---------------------------------------------------------
MCRA, an IQVIA business, is the leading therapy focused global full-service medical device, diagnostics & biologics CRO & consulting advisory firm.
MCRA is the pioneer and leader in integrating its core service offerings to bring healthcare innovation to the market globally, from conception to commercialization.
Our team of industry leading talent, including former FDA reviewers, notified body decision makers, clinical subject matter experts, reimbursement veterans and payers, provides in-depth therapeutic knowledge and thorough market understanding to each project we take.
MCRA's Service Offerings:
Full Service Clinical Research Organization
Global Regulatory Support
US Regulatory Support
Reimbursement, Healthcare Economics & Market Access
Quality Assurance & Quality Operations
Healthcare Compliance
Cybersecurity
Due Diligence
AI & Imaging Center
Talent Solutions
Learn more about MCRA at www.mcra.com.
มุมมอง: 100
วีดีโอ
Category III CPT Codes: Challenges and Opportunities - MCRA Webinar
มุมมอง 1773 หลายเดือนก่อน
Category III CPT Codes: Challenges and Opportunities Webinar Category III CPT codes have a reputation for being relatively easy to obtain, but often difficult to get reimbursed. Category III codes are often an underappreciated opportunity for establishing premium payment. Join MCRA’s Reimbursement experts John McDermott, Chaya Chavez, and Dr. Joel Brill for a deep dive into practical considerat...
LDT vs IVD: Adapting to the New FDA Regulations - MCRA Webinar
มุมมอง 4655 หลายเดือนก่อน
The US FDA recently released its final rule on the regulation of Laboratory Developed Tests (LDTs). MCRA’s IVD experts have been proactively engaged in understanding and preparing for this significant regulatory development, including analyzing the quality and clinical implications. Join us as we delve into the timeline for enforcement, the key aspects of the ruling, and how your organization c...
Reimbursement Considerations in Product Commercialization - MCRA Webinar
มุมมอง 3876 หลายเดือนก่อน
Market Access and Reimbursement are often overlooked when a product is being brought to market. Unfortunately, this can result in numerous issues and delays in the adoption process for a new technology. By taking early action, companies can avoid many problems which can limit their uptake in the market. In this webinar, MCRA experts Michael Anselmo, John Schmitt, Anne O'Brien and Nicole Fitzpat...
Transition from EFS to Pivotal for Implanted BCI Devices - MCRA Webinar
มุมมอง 1387 หลายเดือนก่อน
Transition from EFS to Pivotal for Implanted BCI Devices: Patient, Regulatory, and Reimbursement Perspectives Webinar All implantable BCI systems are currently in the early feasibility stage. Historically, most of these studies were investigator sponsor studies that were academically based and fell within the category of Early Feasibility Studies (EFS). In the last few years, medical device man...
FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech
มุมมอง 1.8Kปีที่แล้ว
In recent months, the US FDA has published several guidance documents related to SaMD, SiMD and connected medical devices that shift the regulatory landscape for both new and experienced medical device companies. This 90-minute webinar provides an overview of these landscape shifts and a panel discussion on the practical implications and applications with experienced regulatory, quality, cybers...
Reimbursement, Market Access Strategy, and the Importance of a Patient Access Program
มุมมอง 2473 ปีที่แล้ว
A video highlighting a portion of a MCRA webinar. The speaker is Tonya Dowd, MPH, our VP of Reimbursement, Health Economics & Market Access. MCRA is the leading therapy-focused clinical research organization (CRO) and consulting firm specializing in global clinical and regulatory affairs, reimbursement and market access, quality assurance, compliance and cybersecurity support for the medical de...
MCRA Webinar Clip 2: MDR Requirements: What is Sufficient Clinical Evidence in Europe
มุมมอง 1853 ปีที่แล้ว
A video highlighting a portion of the webinar on Navigation of MDR Expectations for Tomorrow Based on Notified Body Feedback Today.
MCRA Webinar Clip 2: Understanding the FDA Breakthrough Device Designation Pathway
มุมมอง 1813 ปีที่แล้ว
A video highlighting a portion of the webinar on FDA Breakthrough Designation Regulatory and Reimbursement Trends: Market From the Former FDA Acting Director of Breakthrough.
MCRA Webinar Clip: Early US Reimbursement & Market Access: It's Not Optional
มุมมอง 2563 ปีที่แล้ว
A video highlighting a portion of the webinar, 'Early US Reimbursement & Market Access: It’s Not Optional', as part of a webinar series. Tonya Dowd, MPH, our VP of Reimbursement, Health Economics & Market Access speaks extensively about topics such as learning and understanding the fundamentals of Reimbursement and Market Access from an early planning standpoint, to how to review a best practic...
Using Patient Access Programs to support patient access to new and emerging technologies
มุมมอง 1833 ปีที่แล้ว
MCRA, LLC partnered with LSX to present a webinar on 'Using Patient Access Programs to support patient access to new and emerging technologies'. Tonya Dowd, MPH, our VP of Reimbursement, Health Economics & Market Access, and Amanda Rhoades, Director of Reimbursement, speak extensively about topics such as learning how Category 3 CPT codes for new technology have evolved, how to determine if a P...
FDA Breakthrough Device Program - Regulatory and Reimbursement Insights
มุมมอง 1.4K3 ปีที่แล้ว
MCRA, LLC partnered with LSX present a webinar on FDA Breakthrough Designation Regulatory and Reimbursement Trends: Market From the Former FDA Acting Director of Breakthrough.
Wound Care Innovation: The Call to Clinical Action
มุมมอง 2003 ปีที่แล้ว
MCRA, LLC partnered with LSX to present a webinar on Wound Care Innovation: The Call to Clinical Action.
The Path to US Market for Digital Health Technologies
มุมมอง 1403 ปีที่แล้ว
MCRA, LLC partnered with LSX to present a webinar on Digital Health US Market Pathways: Navigating an Evolving Regulatory Framework.
Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape
มุมมอง 1583 ปีที่แล้ว
MCRA, LLC partnered with LSX to present a webinar on Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape.
LSX London 2021 Medtech Virtual Congress - Evidence Generation For Optimal Market Adoption
มุมมอง 343 ปีที่แล้ว
LSX London 2021 Medtech Virtual Congress - Evidence Generation For Optimal Market Adoption
The Future of Medical Devices: How COVID-19 and the Rise of Digital Health has changed the landscape
มุมมอง 1383 ปีที่แล้ว
The Future of Medical Devices: How COVID-19 and the Rise of Digital Health has changed the landscape
Early US Reimbursement & Market Access: It's Not Optional
มุมมอง 2.9K3 ปีที่แล้ว
Early US Reimbursement & Market Access: It's Not Optional
Navigating MDR expectations for tomorrow based on Notified Body feedback today
มุมมอง 613 ปีที่แล้ว
Navigating MDR expectations for tomorrow based on Notified Body feedback today
Considerations for Orthopedic Implant Associated Antimicrobial Agents: Regulatory Science
มุมมอง 4383 ปีที่แล้ว
Considerations for Orthopedic Implant Associated Antimicrobial Agents: Regulatory Science
Miller Matthew Moore Dorothy Garcia George
very informative video, can I have copy of presentation for learning purpose
Informative presentation, Thanks Dr Mehdi and MCRA LLC. Regards- Ramim Anti-microbial peptide researcher