By : Compliance Online
Date : 2012
Location : California / Palo Alto
Understand what is the CER and how to prepare for and defend it and properly constructing a "bullet-proof Technical File and manage your documentation.
CER, clinical Evaluation reports, medical devices compliance, clinical data, regulation, medical devices training.
As industry is aware of, now you must deal with the new requirements for Clinical Evaluation Reports (CER's) if you sell all classes of medical devices in Europe. As of March 2010, and fast approaching, every medical device, including Class I and Class IIa, will be required to have a Clinical Evaluation Report (CER) in its Technical File. Annex I of the amended MDD basically is driving this with the DoC with the Essential Requirements. Translation for device firms - every medical device sold in Europe will have a CER.
This Webinar will go through the construction phase of the Technical File and the CER but from a general overview and snapshot. There are resources to help manufacturers including the Global Harmonization Task Force (GHTF), which published a guidance on clinical evaluation (SG5/N2R8: 2007). Don't forget, along with the Annexes, another valuable reference for guidance on developing a clinical evaluation report is the European Commission's guidance document MEDDEV 2.7.1, Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies. For those who sell in the EU, as a reminder, many Class I and Class IIa device manufacturers will have to add clinical evaluations to their current technical documentation...bottom line...all classes of devices are impacted.
Who Will Benefit:
This webinar will provide valuable assistance and guidance to companies who need to better understand what the CER is and how to prepare for and defend it and properly constructing a "bullet-proof Technical File. The employees who will benefit include:
- All end-users from appropriate departments who desire or require a better understanding or a refresh knowing that every medical device sold in Europe must be supported with a Clinical Evaluation Report in its technical file.
- Regulatory Affairs Management and RA Specialists
- Clinical Affairs
Areas Covered in the Seminar:
- Learn the latest new term - "Clinical Data" - as defined in the relevant modified ERs and why this data requires a clinical "eval".
- Understand the Essential Requirements and the relationship to the Clinical Evaluation Report.
- Prepare and execute a literature review.
- Define the elements comprising the CER and recommended format.
- Construct a Technical File from start to finish to make it bulletproof.
- Comprehend the expectation that every device sold in Europe, regardless of its classification, must have a CER in its Tech File.
- Learn what resources exist to guide the manufacturer in developing a clinical evaluation report, including how to select a format for writing it and keeping it updated.
David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.
Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.
Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.
He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.
Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.
Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
Mr. Dills’ academic degrees include Environmental Science and Biology. He currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria