Course "Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Why you should attend
Introduction to MEDDEV 2.7.1, Revision 4 (2016)
This revised MEDDEV is generated within a context of increased scrutiny on the Notified Bodies (NB) by the Joint Assessments from the Competent Authorities, which has led to an increase in the level of review the NB exercise over clinical evaluations
Frequency for updating the CER is also much more prescriptive now and you must define and justify the frequency, based on "significant risk" of the device, as well as how "well-established"
One of the largest changes in this revision, the demonstration of "equivalence" is much harder now
Revision will lead to more clinical investigations, probably of larger size and notified bodies will be looking more closely at how all the essential requirements are met, including those regarding usability
Manufacturers should start discussing with their notified bodies how they will start implementing these new requirements and to start performing their gap assessments and resource needs-assessments now
General considerations on updating the clinical evaluation
How is a clinical evaluation performed?
Appraisal of pertinent data
The role of the notified body in the assessment of clinical evaluation reports and key changes in 2016
Implement risk evaluation pre/post review
Establish design and intended use equivalence with competitor and preexisting designs
Identify data available from the clinical literature
Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements (if clinical investigation was deemed necessary and completed)
Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
Identify residual clinical risks and determine whether post-market clinical follow-up is required
Maintain and update clinical evaluation documentation throughout post-market product lifecycle
The initial creation of a CER can be a painstakingly long process, and for smaller manufacturers, can prove quite burdensome - learn how to complete a literature review report which is a comprehensive analysis of available pre- and post-market clinical data relevant to the intended use of the device and includes clinical performance and safety data
Learn how the new MDR for Europe has a direct impact on the CER going forward
Why CERs need to be reassessed under the new MDR
Learn how to plan for a gap assessment to transition an organization to compliance for your CER under Europe's Medical Device Regulation 2017/745
Who will benefit:
Personnel who want to know all aspects of the CER process and MEDDEV and the impact from the new MDR for EU. Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. Employees and personnel who will benefit include:
All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of MEDDEV 2.7.1, Revision 4
Senior Management
Regulatory Affairs Managers and RA SME's
Quality Managers
Design, Development, Manufacturing and Marketing Managers
Auditors
Regulatory Affairs professionals
QA/QC professionals
Project Managers
Compliance Officer
Compliance Specialist
Clinical Affairs
Marketing & Sales Management
Distributors/Authorized Representatives
Legal Counsel
Consultants
CRO's
RA Specialists
Clinical Affairs
Project Leaders for MEDDEV and CER Compliance
Agenda:
Day 1 Schedule
Lecture 1:
Clinical Evaluation Report and MEDDEV
Define Scope and Plan the Clinical Evaluation
Clarification: Frequency of updates to the Clinical Evaluation Report (CER)
Identification of Pertinent Data
Appraisal of Pertinent Data
Analysis of Clinical Data, Draw Conclusions
Finalize the CER: What should it look like?
New requirement: Qualifications of report authors and evaluators
Specific and measurable objectives for the CER
Establishing the state of the art
Scientific validity of data
Equivalence
Access to data for equivalent devices
When is a clinical investigation required?
Risk-benefit
Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)
Table of Contents for a CER (example)
Given the guarantee that all clinical support documentation is going to need to be re-evaluated and revised to meet the new legislative criteria under the new MDR, coupled with the realization that Notified Bodies are going to be inundated, we need to embark on clinical compliance now
Day 2 Schedule
Lecture 2:
Clinical Evaluation Report and MEDDEV
CER Assessment
Clinical Evaluation Plan and Strategy
Clinical Literature Review Safety and Performance and Examples
Preparing, writing and filing a new CER
Conducting a comprehensive literature review and formal assessment
Conduct a Literature Review in a few easy steps
Performing yearly gap analyses of MEDDEV regulations versus the existing CER
Creating timelines for updating existing CERs, training staff
Updating existing CERs
Ensuring compliance with new requirements
Any upfront or follow-on processes that may help drive commercialization
Clinical Evidence"? Put simply:
Clinical Data + Expert Review = Clinical Evidence
References and Guidance
Industry Trends
Lecture 3:
Consulting Case Study Practice
Participants role play consulting with instructor on CER examples
Avoid frequent pitfalls of clinical regulatory submissions
Provide robust documentation in support of the clinical safety and performance of your device
Ensure continuing compliance throughout device lifecycle
Lecture 4:
Case Study Practice
Practice on a project relevant to participants' organization
Best Practices and Trends - A good clinical evaluation is not just a European thing. It can be enormously helpful in a 510(k) in addressing equivalence with predicate device(s). After all - that's what a literature review is partly doing - looking at (all the) other devices in the market and their performance as it is relevant to your device.
Lecture 5:
Interactive Exercises and Discussions
Case studies
Examples
FAQ's
Q&A
Questions and Summary
Recap of Day 2
Speaker
David R. Dills
Global Regulatory Affairs & Compliance Consultant and President, NovaQual
David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities, by medical device manufacturers and consultancies, including a globally recognized CRO, and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters,483 observations, and customer generated compliance events. He prepares for and conducts QS and regulatory audits He is currently acting and interim President at NovaQual LLC.
Location: Zurich, Switzerland Date: August 1st & 2nd, 2018 and Time: 9:00 AM to 5:00 PM
Venue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland
Price:
Price: $1,695.00 (Seminar Fee for One Delegate)
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Sponsorship Program benefits for seminar
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