Presentation at the MedTech Summit 2018 in Brussels concerning the new EU regulatory regime for economic operators in the supply chain of medical devices and IVDs
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
Liability insurance requirements under the new EU Medical Devices Regulation ...Erik Vollebregt
Presentation at the Q1 conference on 23 May about the new liability regime likely to be imposed under the new new EU Medical Devices Regulation and In Vitro Diagnostics Regulation.
Presentation at the MedTech Summit 2018 in Brussels concerning the new EU regulatory regime for economic operators in the supply chain of medical devices and IVDs
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
Liability insurance requirements under the new EU Medical Devices Regulation ...Erik Vollebregt
Presentation at the Q1 conference on 23 May about the new liability regime likely to be imposed under the new new EU Medical Devices Regulation and In Vitro Diagnostics Regulation.
Presentation at the Advamed MedTech conference in Boston on 25 September regarding the state of implementation of the EU Medical Devices Regulation MDR, and what companies can still do before its date of application on 26 May 2020
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
Use of left over samples under the IVDR and GDPRErik Vollebregt
Presentation on the RAPS Convergence 2017 about the use of left over samples in performance evaluation under the In Vitro Diagnostics Regulation (IVDR) and under the General Data Protection Regulation (GDPR)
This presentation describes regulatory hurdles to keep in mind when acquiring / selling medical devices companies with CE certificates to prevent them from becoming invalid.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
The Top 10 Most Significant Changes Introduced by the New EU MDR (and how to ...Greenlight Guru
As most of you have likely heard, the EU's new Medical Device Regulations (MDR) went into effect earlier this year replacing the old MDD and setting in motion a three-year countdown for manufacturers to comply to continue selling in the European market.
You also likely have a lot of questions about what do these changes mean, how can you begin preparing, how will they affect your company, what are their greatest implications, etc.?
Specifically, this presentation covers:
-How much will the new Medical Device Regulation cost?
-Why did it need to happen and what is the new structure?
-What additional activities does a manufacturer have to carry out?
-What are the top 10 most significant changes?
-What is EUDAMED and how has its role changed?
-And much more...
Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-most-significant-changes
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Presentation at the Advamed MedTech conference in Boston on 25 September regarding the state of implementation of the EU Medical Devices Regulation MDR, and what companies can still do before its date of application on 26 May 2020
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
Use of left over samples under the IVDR and GDPRErik Vollebregt
Presentation on the RAPS Convergence 2017 about the use of left over samples in performance evaluation under the In Vitro Diagnostics Regulation (IVDR) and under the General Data Protection Regulation (GDPR)
This presentation describes regulatory hurdles to keep in mind when acquiring / selling medical devices companies with CE certificates to prevent them from becoming invalid.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
The Top 10 Most Significant Changes Introduced by the New EU MDR (and how to ...Greenlight Guru
As most of you have likely heard, the EU's new Medical Device Regulations (MDR) went into effect earlier this year replacing the old MDD and setting in motion a three-year countdown for manufacturers to comply to continue selling in the European market.
You also likely have a lot of questions about what do these changes mean, how can you begin preparing, how will they affect your company, what are their greatest implications, etc.?
Specifically, this presentation covers:
-How much will the new Medical Device Regulation cost?
-Why did it need to happen and what is the new structure?
-What additional activities does a manufacturer have to carry out?
-What are the top 10 most significant changes?
-What is EUDAMED and how has its role changed?
-And much more...
Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-most-significant-changes
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Sustainable Procurement Index for Health (SPIH) ClinicUN SPHS
Delivered by Arup at the Global Forum 2020 Sustainable Procurement Index for Health Clinic session.
Presenters:
Dr. Kristian Steele, Associate, Arup
Ms. Anna Tuddenham, Consultant, Arup
Mr. Terry Ellis, Senior Consultant, Arup
Mr. Callum Newman, Associate Director and Group Leader for International Development, Arup
AN ISO SCHEME FOR USE AS A REVIEW GUIDE OR FOR CERTIFICATION OF PERFORMANCE-B...Dr. Monideep Dey
This paper proposes development of an ISO scheme that could be used either as a review guide or for the certification of a performance-based fire safety design in accordance with ISO 23932 – Fire Safety Engineering: General Principles . Deytec, Inc., a company member of the American National Standards Institute (ANSI), plans to propose the development of this ISO scheme to the ANSI International Conformity Assessment Committee (ICAC) which is the U.S. interface to the ISO Council Committee on Conformity Assessment (ISO CASCO). ISO CASCO writes standards and guides for the effective operation of conformity assessment bodies and activities. The purpose of the proposed scheme is to address present issues faced by national authorities and applicants in the review and approval of performance-based fire safety designs.
Monideep Dey, PhD
President, Deytec, Inc.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
Keeping a finger on the pulse of regulatory changes taking place worldwide is hard to do, but nonetheless imperative. This presentation will provide a high-level overview of the more significant global regulatory changes that will impact orthopaedic manufacturers in the next two years. These include European Medical Device Regulation, ISO 13485:2016, MDSAP and U.S. FDA changes, as well as other global topics of interest. Ms. Loh, who leads the regulatory team at EMERGO, returned to OMTEC to provide perspective on strategies and risks to consider with these wide-ranging and sometimes overlapping matters.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Detailed Project Report on Rapid Diagnostic Test Kit Manufacturing Unit SetupIMARC Group
The report provides a complete roadmap for setting up an rapid diagnostic test kit manufacturing plant. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
More Info:- https://www.imarcgroup.com/rapid-diagnostic-test-kit-manufacturing-plant-project-report
UL Webinar - Updates to the Regulatory Framework in Korea and their impact to...ulmedical
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.
Similar to Advamed EU MDR and IVDR panel presentation (20)
Managing New Requirement for Economic Operator RegimeErik Vollebregt
Presentation of new economic operator regime under the new EU Medical Devices and IVDs Regulations, delivered at the Q1 Medical Devices Regulation conference on 16 July 2019
3D medtech printing under EU Medical Devices Directive and under future Medic...Erik Vollebregt
3D medtech printing conference maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
Presentation delivered at the RMD 2016 conference (European Symposium on the New Agreed Draft Regulations on Medical Devices) in Prague on 7 November 2016
EU cybersecurity requirements under current and future medical devices regula...Erik Vollebregt
Presentation delivered at Q1 MEDICAL DEVICE CYBERSECURITY RISK MITIGATION conference in Washington on 25 July 2016 concerning EU cybersecurity requirements under current and future medical devices regulation
Presentation about transparency under the new MDR and IVDR at Informa Medtech Summit in Clinical evaluations and investigations for medical devices track
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
1. ADVAMED MDR AND
IVDR PANEL
Advamed EU MDR and IVDR panel
25 September 2017
Erik Vollebregt
www.axonadvocaten.nl
2.
3. Your panel
Moderator:
• Erik Vollebregt, Axon Lawyers
Speakers:
• Oliver Bisazza, Director Industrial Policy and Regulations, MedTech
Europe
• Ibim Tariah, Technical Director at BSI Americas Inc, BSI
• Jon L Lange, Principal Life Sciences, EY
• Hilde Viroux, Global EU MDR Compliance, Alcon
4. Some questions to
help you sleep better
• Who has a copy of the MDR or IVDR?
• Who has read it completely?
• Who understands it (sort of / completely)?
• Whose company has done a gap assessment?
• Whose company has done an impact assessment based on the
gap assessment?
• Whose company made a transition / implementation plan?
• Whose company has decided for each of its devices if it will
remediate, retire or replace it for the EU market?
• Whose department was allocated sufficient resources to
implement the transition plan?
• Whose company thinks it will complete transition in time?
5. No grandfathering and no moving
of implementation deadlines
• All devices on the market are phased
into the new system by the end of
transitional period
• This means that you have to do a
new conformity assessment under
the new rules for all devices
currently on the market or remove
the product from the market
• If you don’t have a new CE under
MDR or IVDR, you cannot place new
product on the market after transition
period
• Do not count on the EU “having to
move deadlines because it will be
chaos”, as this would be
unprecedented
9. Page 9
Critical considerations
Each product/product family across the portfolio will be implicated and
additionally aspects of your Operating model may need to be modified.
► Each product/family can be implicated differently. .
► Implementation will have to be conducted for all products
► Assessment needs to be conducted under each change element in the new Legislation, implementation needs to be
planned holistically due to interdependencies in remediation eg ( RS, Clinical, Tech File, Labelling)
Product change impacts
Regulatory
• Technical Files / GSPR
• Labelling/ DoC / IFU/UDI
• Up classification/Classification
• Re-processing
• Scrutiny
Labelling
• UDI
• Implant Cards
• IFU/DFU
• Medical device symbol
Clinical
• CER/PER
• PMCF
Product Design/Dev
• Restricted Substances
Operating Model change impacts
PMS
• Complaint Handling process capability
• Vigilance reporting/PSUR
Supply Chain
• UDI system technology
• SC traceability system
Quality Assurance
• QMS/Re-certification
• Notified Body
Regulatory
• Re-registration
• PRRC
• Economic Operator compliance
10. Page 10
Holistic implementation approach
Strong governance for a controlled implementation of key elements
The planning of the implementation is driven by:
► Recertification of the QMS
► Reregistration audit cycle
► Availability of resources/ capacity – Clinical Evidence & Notified Bodies
► Commercial prioritization
Key elements of the implementation are:
A. Product remediation (through remediation playbook)
B. Business operating model (through deployment playbook)
C. Business continuity, sustainability, and NPD
Governance - These key elements are tracked and controlled by EPMO in the Implementation masterplan
Governance
QMS
recertification
B. Business Operating Model Remediation
A. Product Remediation
C. Business
Continuity
Commercial Prioritization
Editor's Notes
Durée de validité des certificats MDD
Choix de date de demande MDR
Durée de validité des certificats MDD
Choix de date de demande MDR