Author Archives: makrocarewebinars

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 … Continue reading

Posted in Regulatory Support, Uncategorized | Tagged , , , | Leave a comment

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 … Continue reading

Posted in CRO and Vendor Oversight Webinar | Tagged , , , , , , | Leave a comment

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 … Continue reading

Posted in RBM Webinar, Uncategorized | Tagged , , , , , , | Leave a comment

Webinar on Strategies for Global Labeling Management in Changing Reg Environment

                                                            Gerrit Jan Nijveldt               … Continue reading

Posted in Labeling | Tagged , , , , , , | Leave a comment

Webinar on Focusing Investigational Sites Risks in RBM

Sponsor’s performance of investigational site risk assessment is essential for effective planning and implementation of clinical trial project. Risk identification starts at the sponsor/CRO system and project level, and also risks are assessed and controlled at site level at pre-study … Continue reading

Posted in RBM Webinar | Tagged , , , , , , | Leave a comment

RAPS & MakroCare invite you for an evening of learning & networking

RAPS & MakroCare is organizing a Seminar on Regulatory Intelligence at Ardmore, PA, USA.The Reg Intelprovides updated regulatory data from multiple sources for IRB/clinical submissions, market authorization, safety reporting, manufacturing, LCM and other details. The speaker of the Seminar is … Continue reading

Posted in RAPS | Tagged , , , , , , , | Leave a comment

Webinar on eTMF – Challenges, Opportunities & Trends

Essential Documents are the evidence that demonstrate Investigators, Sponsors, and Monitors have met the expectations of Good Clinical Practices (GCPs) and related regulations. The documentation stored in the Trial Master File is becoming increasingly digitized driving eTMF adoption across the … Continue reading

Posted in eTMF | Tagged , , , , , , , | Leave a comment