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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Webinar on Strategies for Global Labeling Management in Changing Reg Environment


Gerrit-Jan-Nijveldt                                                           Carlos-Langezaal

Gerrit Jan Nijveldt                                                  Carlos Langezaal
Senior Director,                                                       Director,
Regulatory Labeling,                                             Global Regulatory Affairs,
Sanofi                                                                          Eisai, Inc.


This is a significant year as far as rule making for labeling is concerned. Several labeling regulations are anticipated this year.  Designing a Product label that is compliant with the current FDA regulations is complex and time taking. Pharmaceutical companies are constantly managing product-labeling documents such as Package Inserts (PIs), Summaries of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). The same information is often duplicated for various product strengths, dosage forms and presentations, resulting in an overwhelming set of labeling records that are difficult to manage and keep synchronized.

If you are part of Regulatory – Labeling team in your company, you should not miss this Webinar. As you are constantly working to coordinate a more robust end-to-end labeling process, and trying to get yourself up to speed on the newest emerging regulations / guidances from FDA and EMA, MakroCare brings you this opportunity to learn about A-Z of Labeling to Global labeling process and practical challenges faced in day-to-day operations from our duo experts Gerrit-Jan Nijveldt, Senior Director, Regulatory Labeling, Sanofi and Carlos Langezaal, PhD, Director, Global Regulatory Affairs, Eisai, Inc. Some of the points being covered are listed below.

Gerrit’s Topic:  “End-to-End Labeling: From Core Labeling Creation to Implementation
•  What is Core Labeling (short version)
•  How to update a CCDS
•  Implementation of core labeling
•  Tracking of implementation why how and what
•  Agency inspection of labeling implementation

Carlos’s Topic:  Eisai’s Global Labeling Practices
•  Who is Eisai Global Labeling and who are the stakeholders
•  Eisai Global Labeling Function
•  Overview of Global Labeling process
•  Practical challenges

Date/ Time: Thursday,May 19th @ 11am EST

Speakers Details:

Gerrit Jan Nijveldt
Gerrit-Jan Nijveldt is currently senior Director, Global Regulatory Affairs Labeling for Sanofi in Bridgewater, NJ. Gerrit and his team are responsible for developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation for the therapeutic area Diabetes and Devices.

Gerrit has an MSc in Medical Biology from University of Utrecht in the Netherlands and started working in pharmaceutical industry in 1991 in the Netherlands and has worked since 1997 in the Global Regulatory Labeling department.

Gerrit is also an associate adjunct professor for Temple University School of Pharmacy teaching Labeling where he teaches in the Quality Assurance and Regulatory Affairs Masters Program.

Carlos Langezaal, PhD
Carlos R. Langezaal, Ph.D., Director, Global Regulatory Affairs, is currently head of the Global Labeling group which is a function in the Global Regulatory Affairs Core Functional Unit at Eisai. The Global Labeling group within Eisai is responsible for a number of tasks including the development, revision, review, and approval of the Company Core Data Sheet and the Country Product Information for all products globally. Previously, he worked at Eisai, Sanofi-Aventis, J&J PRD, Schering-Plough, Core Technologies, Eli Lilly, and Baxter in various therapeutic areas, including oncology, allergy, respiratory and internal medicine. He has more than 20 years of experience in regulatory affairs, having worked in the device, device/drug combination products, CMC and clinical/non-clinical development areas primarily with a global focus.

For More Information Mail to : info@makrocare.com

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