Webinar on Importance & Requirements of Clinical Evaluation for CER

MC CER Webinar

The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations. A sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient evidence to demonstrate conformity with relevant essential requirements for performance and safety is very critical. The demonstration of “equivalence” between subject device and predicate is much stricter now and may lead to requirement of generating more clinical data with larger patient populations. The importance of an overall evaluation of the device needs to be emphasized with particular focus on ensuring that clinical data are evaluated in a systematic and objective way, that the benefit/risk profile is acceptable and any knowledge gaps are identified and addressed. Considering the importance & requirement of clinical evaluation for CER writing and updating, this webinar is planned to focus on the following aspects.

  • 5 stages of Clinical evaluation
  • New Requirements for justifying Equivalence
  • PMS & PMCF
  • Qualifications of the Evaluators
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Webinar on Growing need of Clinical Data, PMCF & Registries for Devices



Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps surrounding past PMCF work are becoming more evident. “Passive” collection of adverse events, complaints and the like may not be sufficient any longer to demonstrate conformity to the Essential Requirements and to the future Medical Device Regulation (MDR). This webinar will review emerging PMCF, Registry needs in this era of pre-MDR business risk evaluations.

Learning objectives:

Tick Bullet Clearly define PMCF, Registry needs for Devices

Tick Bullet Apply CER gaps in safety and performance clinical data to PMCF & registry designs

Tick Bullet Differentiate adequate PMCF plans from less than adequate PMCF plans

Tick Bullet Alternate methods of getting Clinical data for your Devices

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Webinar on Explore rSDV for Clin Ops efficiency & Cost Saving






While on-site monitoring is one of the biggest cost drivers of clinical trial operations, Remote Source Document Verification (rSDV) offers the best alternative to significantly reduce onsite monitoring activities to build efficiencies, data quality and assure human subject protection.

This webinar will explore the differences between rSDV and other monitoring methods, how to maintain subject privacy in the process of collecting source documents and what 21 CFR Part 11 requires, strategies for remote review of source documents at sites that do not utilize electronic medical records. Explore the great benefits of rSDV and for the types of studies it can be leveraged in a big way.

This webinar covers:

  • Remote Source Document Verification (rSDV) process
  • Strategies & challenges in implementing rSDV
  • Benefits of rSDV
  • Subject confidentiality & 21 CFR Part 11 requirements
  • CRA compliance in remote setting

Speaker Details:

Laura LaRosa, RN MS
Quality Management Strategist &
Investigative Compliance specialist

Date & Time:

Tuesday, 27th June
11 AM -12 Noon EST
5 PM – 6 PM CET

For further details mail us at webinar@makrocare.com

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Webinar on Matured/Established Products Regulatory Support & Models

Matured products go through multiple decisions in Global organization like: Keep or divest? Same teams or different teams to handle them? For regional support, who should pay? and more. All these stemming from cost pressures in global markets and changing regulatory environment. Whether you are part of the Regulatory group in an emerging/mid-size/large global Biopharma organization with aging product portfolio or a Generic company with multiple products whose licenses need to be maintained, do not miss this upcoming Webinar on Mature Products.
Our speaker, Chand Sishta, Director Global Regulatory Sciences, Mature Products at Bristol-Myers Squibb will focus on current challenges and what the future holds for them. Some of the points being covered are listed below:
Tick Bullet  What is a mature/established product
Tick Bullet  How do health authorities view mature/established products
Tick Bullet  What challenges are encountered for these products in international markets
Tick Bullet  How does information gathered via regulatory intelligence impact these products
Tick Bullet  How do these Mature Products thrive when generics are available in marketplace
Tick Bullet  How to manage compliance effectively
About Our Speaker:

Chand Sishta is currently Director, Global Regulatory Sciences, Mature Products at Bristol-Myers Squibb Company located in Lawrenceville, NJ.

Chand received his Ph.D. from the University of British Columbia, Vancouver, B.C. in 1990 and completed a Post-Doctoral Fellowship at Northwestern University from 1990 to 1992. He started as a discovery scientist with Union carbide Corporation in Bound Brook, NI in 1992 and this role led to significant interactions with large manufacturing plants. Consequently, he worked as a FDA Regulatory Manager at Union Carbide. Chand then worked for Bristol-Myers Squibb from 2000 to 2005 as Quality Assurance for the development division of BMS located in New Brunswick, NJ. From 2005 to 2011, Chand worked for Pfizer as Regulatory CMC located in Peapack, NJ.

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LIVE WEBINAR How effective is your CRO and Vendor Oversight ?


Oversight is YOUR responsibility no matter what you outsource and to which vendors you work with. You are accountable fully in the eyes of healthcare regulators and Patients alike. Join us on this webinar to explore some best practices and benchmark how you are doing currently on risk management and compliance areas that feed into your overall Oversight. This webinar is designed to cover following aspects:

  • Criticality of Oversight in clinical projects
  • Developing an effective Oversight plan
  • Selecting right areas to oversee, metrics and risk management planning
  • Add compliance, RBM and Central Monitoring also to the same plan as an option
  • See how technology is key enabler to Oversight

Date: Wednesday, 16th Nov, 2016

Time: 11 AM EST

Sandra “SAM” Sather,
Clinical Operations & Risk Expert

For further details mail us at webinar@makrocare.com

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Webinar on Next Generation of Central Monitor and Monitoring in RBM-Industry Updates


With the inclusion of centralized monitoring in risk based monitoring (RBM) approach; the Central Monitor is emerging as a key and important role in successful implementation of this new monitoring approach. The role of the Central Monitor and function of central monitoring is only just being introduced or is yet to be introduced but we already need to be flexible to adapt to changes. These changes are due to multiple factors.

•  New regulations and guidance
•  2nd and 3rd generation methods
•  2nd generation RBM tools

This will webinar will discuss the impact of these changes on roles and functions.

Date: Tuesday, June 21, 2016

Time: 11:00 AM EST


Andy Lawton
RBA Consultant, Formerly Global Head of Clinical Data Management
at Boehringer Ingelheim

Ashok Ghone, Ph.D.
VP-Global Services, MakroCare, USA

For further details mail us at webinar@makrocare.com


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