The document discusses new post-market surveillance and vigilance obligations for economic operators in the medical device supply chain under revisions to the Medical Device Directive. It defines roles for manufacturers, authorized representatives, importers, and distributors, assigning responsibilities to ensure device quality and safety at each stage. These include oversight of conformity assessments, labeling, reporting issues and recalls. Concerns are raised about overlapping responsibilities adding burden without benefit. Clear definition and allocation of roles is important to avoid catastrophic effects on the supply chain.
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
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 Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
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
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 Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
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.
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
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
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
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
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given device...
The Quality Metrics Program is an FDA initiative aiming to collect data on certain manufacturing processes from biopharmaceutical companies through an electronic portal.
This presentation describes the impact of the program and its challenges for the industry.
General Data Protection Regulation (GDPR) - Cross-Border Data Transferspi
The General Data Protection Regulation will Impact all health data processing companies because of the growing importance of customer and patient data to the manufacturer’s business. All companies have to be compliant by 25th May 2018.
This presentation gives an overview of all the possibilities included in the GDPR to allow Cross-Border Data Transfers to third countries.
Medical Devices Postmarket Surveillance in Europe updatedAnnet Visscher
Medical Device Postmarket Surveillance and Clinical Follow-up under the proposed European Medical Device Regulation updated according to the latest amendments.
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
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.
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
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
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
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
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given device...
The Quality Metrics Program is an FDA initiative aiming to collect data on certain manufacturing processes from biopharmaceutical companies through an electronic portal.
This presentation describes the impact of the program and its challenges for the industry.
General Data Protection Regulation (GDPR) - Cross-Border Data Transferspi
The General Data Protection Regulation will Impact all health data processing companies because of the growing importance of customer and patient data to the manufacturer’s business. All companies have to be compliant by 25th May 2018.
This presentation gives an overview of all the possibilities included in the GDPR to allow Cross-Border Data Transfers to third countries.
Medical Devices Postmarket Surveillance in Europe updatedAnnet Visscher
Medical Device Postmarket Surveillance and Clinical Follow-up under the proposed European Medical Device Regulation updated according to the latest amendments.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
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...
No substantial changes compared to 2004/108/EC (for manufacturers)
Conformity Assessment Procedure: two options
Module A “Internal production control”
Module B “EU type examination” + Module C “Conformity of type based on internal production control”
To improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU Market, the New Legislative Framework was adopted in 2008
improves market surveillance rules to better protect both consumers and professionals from unsafe products, including those imported from outside the EU:
- sets clear and transparent rules for the accreditation of conformity assessment bodies;
- boosts the quality of and confidence in the conformity assessment of products through stronger and clearer rules on the requirements for the notification of conformity assessment bodies;
- clarifies the meaning of CE marking and enhances its credibility;
- establishes a common legal framework for industrial products in the form of a toolbox of measures for use in future legislation.
Presentation about transparency under the new MDR and IVDR at Informa Medtech Summit in Clinical evaluations and investigations for medical devices track
Medical Devices - Servicing Medical Device CompaniesIBMElectronics
The medical device industry is in the midst of fundamental change. IBM’s approach to servicing medical device companies is designed to meet real-world needs today and in the future.
mHealth Israel_EU MedTech and eHealth Regulatory FrameworkLevi Shapiro
Presentation by Hogan Lovells, EU MedTech and eHealth Regulatory Framework. Best practices and key changes in the European medtech regulatory environment, 2018.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
Presentation delivered at the RMD 2016 conference (European Symposium on the New Agreed Draft Regulations on Medical Devices) in Prague on 7 November 2016
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
Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessmentsTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Presentation at the 29-30 January 2014 Informa Medical Devices Revision conference in Brussels regarding developments in relation to the Eudamed database and its rule in the new EU medical devices system
Similar to Economic operators and post market surveillance under the proposed EU medicinal devices regulatione (20)
This presentation describes regulatory hurdles to keep in mind when acquiring / selling medical devices companies with CE certificates to prevent them from becoming invalid.
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
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)
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
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
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
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ASA GUIDELINE
NYSORA 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.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...
Economic operators and post market surveillance under the proposed EU medicinal devices regulatione
1. MEDICAL DEVICE
POST MARKET
SURVEILLANCE AND
VIGILANCE
Informa Medical Device Post Market Erik Vollebregt
Surveillance and Vigilance www.axonadvocaten.nl
27 February 2013
2. Introduction + agenda
• Understanding how the roles of the economic operators are expected to
be defined in the revision of the MDD
• Examining new PMS obligations for various operators in the medical
devices supply chain as a result of the revision of the MDD
• How to implement overlapping responsibilities of economic operators in
supply and distribution agreements
• Clarifying autonomous responsibilities of operators in the supply chain of
medical devices
3. Economic operators
The MAID:
• Article 2: „economic operators‟ means the manufacturer, the authorised
representative, the importer and the distributor;
Proposal implements strict supply chain control mechanism
• Blueprint from new new approach decision 768/2008
• As implemented in other specific instruments, e.g. toys and falsified
medicinal products directive
• Goal: enlist supply chain in market surveillance by imposing
autonomous obligations on the various stages of the supply chain
4. Definition of importer
Article 2 „importer‟ means any natural or legal person established within the
Union who places a device from a third country on the Union market;
„placing on the market‟ means “the first making available of a device, other
an investigational device, on the Union market”;
• placing on the market is neutral as to goods and services, online and
offline
5. Economic operators: importers
Must ensure that:
1. the appropriate conformity assessment procedure has been carried out
by the manufacturer;
2. an authorized representative in accordance with Article 9 has been
designated by the manufacturer;
3. the EU declaration of conformity and the technical documentation have
been drawn up by the manufacturer;
4. the device bears the required CE marking of conformity;
5. the device is correctly labeled and accompanied by the required
instructions for use and EU declaration of conformity;
6. a Unique Device Identification has been assigned;
6. Economic operators: importers
Must furthermore:
1. Be able to identify any economic operator to whom they have supplied
a device, any economic operator who has supplied them with a device
and any health institution or healthcare professional to whom they have
supplied a device for a period of five years;
2. Label the device with their contact details;
3. Take corrective action (a.o. recalls and report to authorities)
autonomously;
4. Engage in post-market surveillance (among other things report
complaints); and
5. Refuse to import devices of which he has reason to believe are not in
conformity with the requirements.
7. Definition of distributor
Article 2 „distributor‟ means any natural or legal person in the supply chain,
other than the manufacturer or the importer, who makes a device available
on the market‟
• any natural or legal person in the supply chain
• Includes resellers, rental companies
• whether online or offline
• makes a device available on the market
• “any supply of a device, other than an investigational device, for
distribution, consumption or use on the Union market in the
course of a commercial activity, whether in return for payment or
free of charge”
8. Economic operators: distributors
Must verify that:
1. the product bears the required CE marking of conformity;
2. the product is accompanied by the information to be supplied by the
manufacturer;
3. the manufacturer and, where applicable, the importer have complied
UDI and importer labeling requirements
9. Economic operators: distributors
Must furthermore:
1. ensure that, while a device is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the general
safety and performance requirements;
2. Label the device with their contact details;
3. Take corrective action (among other things undertake recalls and report
to authorities) autonomously;
4. Engage in post-market surveillance and vigilance (i.e., report
complaints)
10. With such supply chain duties, do
we still need authorised reps?
Yes, AR must at least:
1. keep the technical documentation, the EU declaration of conformity
and, if applicable, a copy of the relevant certificate including any
supplement issued at the disposal of competent authorities for the
applicable period;
2. in response to a reasoned request from a competent authority, provide
that competent authority with all the information and documentation
necessary to demonstrate the conformity of a device;
Notably only AR is „allowed and required‟ to terminate the mandate if the
manufacturer acts contrary to his obligations under this Regulation.
11. Criticism on supply chain regs
COCIR:
• “several of the described tasks overlap and thus add unnecessary administrative
burden with no obvious benefit for the patients.”
• “COCIR suggests that the importer obligations should only apply in situations
where there is no organisational or legal relation (contract) between the
manufacturer and the importer and the manufacturer has appointed an
Authorised Representative in the EU. “
Eucomed:
“It is absolutely essential that the overlapping obligations and responsibilities of
different economic operators be clarified in the areas of device registration, vigilance
reporting and market surveillance. The definition of clear roles and responsibilities for
economic operators is not only critical to the functioning of the system, it is critical to
the way the supply chain to hospitals and patients work. If not done correctly, it could
have catastrophic effects on certain operators and SMEs within the supply chain,
effectively closing their businesses overnight and risking unavailability or increased
costs to hospitals and patients.”
12. Dealing with overlapping
responsibilities in supply chain
• regulatory compliance upstream
• If importer/distributor considers or has reason to believe that a
device is not in conformity, he shall not make the device available
on the market until it has been brought into conformity.
• Importer must do sample checks if appropriate regarding to risk
• autonomous post-market surveillance obligations
• If reason to believe that a device is not in conformity: immediately
inform the manufacturer and make sure that the necessary
corrective action to bring that device into conformity, withdraw or
recall it, if appropriate, is taken
• immediately forward to manufacturer “complaints or reports from
healthcare professionals, patients or users about suspected
incidents related to a device they have made available”)
13. Post Market Surveillance
Provisions in
• Article 8 (6) Manufacturer must have and implement post market
surveillance plan
• Chapter VI of new MDR (Clinical evaluation and clinical investigations)
• Article 49: Manufacturers shall conduct a clinical evaluation in
accordance with the principles set out in this Article and Part A of
Annex XIII
• Annex XIII pre-market clinical evaluation and post-market clinical follow-
up
• Part A (pre) Clinical evaluation
• Part B Post Market Clinical Follow Up - includes PMCF plan
14. Post Market Surveillance
• Article 8 (6): “The post-market surveillance plan shall set out the process
for collecting, recording and investigating complaints and reports from
healthcare professionals, patients or users on suspected incidents related
to a device, keeping a register of non-conforming products and product
recalls or withdrawals, and if deemed appropriate due to the nature of the
device, sample testing of marketed devices. Part of the post-market
surveillance plan shall be a plan for post-market clinical follow-up in
accordance with Part B of Annex XIII. Where post-market clinical follow-
up is not deemed necessary, this shall be duly justified and documented
in the post-market surveillance plan.”
• Process must be implemented in supply chain
15. Post Market Surveillance
Post Market Surveillance as we know it will be pro-actively laid down in the
manufacturer‟s post market surveillance plan (Annex XIII part B):
• “Post-market clinical follow-up, hereinafter: PMCF, is a continuous
process to update the clinical evaluation referred to in Article 49 and Part
A of this Annex and shall be part of the manufacturer's post-market
surveillance plan. To this end, the manufacturer shall proactively collect
and evaluate clinical data from the use in or on humans of a device
which is authorised to bear the CE marking, within its intended purpose
as referred to in the relevant conformity assessment procedure, with the
aim of confirming the safety and performance throughout the expected
lifetime of the device, the continued acceptability of identified risks and
to detect emerging risks on the basis of factual evidence.”
16. Implementation of PMS in supply
chain
In addition to the usual provisions account for autonomous obligations on
the part of importers and distributors:
• implement mechanism for importer / distributor to check upstream
compliance and consequences on both sides
• ensure that manufacturer is always informed of autonomous action
undertaken – preferably consulted (implement RACI for autonomous
obligations)
• account for consequences of autonomous action
• manufacturer‟s reputation is on the line
• autonomous action impacts entire supply chain – ensure
appropriate liability and indemnities
18. So … is this the final word?
• Looks like it – method chosen for supply chain is the Decision 768/2008
system (articles R4 and R5) which has already been implemented in CE
directives (e.g. toys) so fully “new new approach” compliant
• Powerful arguments necessary to convince Commission to depart from
system
19. Thanks for your attention
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal READ MY BLOG:
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