Article Index

EU IVDR–Performance Evaluation & Data Requirements
Webinar: EU IVDR Performance Evaluation, Data Requirements & Gaps
As some of you are aware, In Vitro Diagnostic Regulation (IVDR) will be effective May 2022. As this regulation has several new requirements, some simple and some complex.

Risk Management EU MDR
Webinar: Risk Management EU MDR Perspective
Risk management is understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.

Medical Device PMS PMCF
Webinar: Medical Device PMS & PMCF: Challenges & Opportunities
The new 2017/745/EU Medical Device Regulations (MDR-2020) require increased emphasis on Post- Market Clinical Follow-Up (PMCF)

Webinar: Importance & Requirements of Clinical Evaluation for CER
The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations.

Webinar: 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.

Webinar: Device Compliance with MEDDEV 2.7.1 Rev 4 for Clin Eval / CER
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device


Webinar: 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.

CRO Vendor Oversight
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.

Webinar: 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.

Global Labeling
Webinar: Strategies for Global Labeling Management in Changing Reg Environment
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.

Webinar: 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.

Outsourcing TO or Not TO
Webinar: Regulatory Outsourcing To or Not To
“To Outsource or Not to Outsource”, the question that many of the companies may be asking. The webinar aims to compare and contrast the advantages & disadvantages.

Webinar: RAPS & MakroCare invite you for an evening of learning and networking
At the RAPS Philadelphia chapter, MakroCare is sponsoring a Seminar on Regulatory Intelligence - It's Not Just a Buzz Word Anymore


Webinar: UDI: Medical Device value chain
Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain.Planning and Implementation of the Medical Device Regulation (UDI)

Webinar: Medical Device Pathway in India
India is one of the largest medical device markets in Asia and it is growing significantly. Medical device market in India is pegged at $6.3 billion in 2013.

Webinar: Centralized Monitoring: A Smart & Cost Efficient Clinical Monitoring Approach Part-II
The right implementation of a centralized monitoring approach is essential in maximizing benefits.

Webinar: Centralized Monitoring: A Smart & Cost - Efficient Clinical Monitoring Approach Part-1
Aggressive financial targets and reduced R&D budget are building tremendous pressures on life science companies to develop new drugs, therapies more quickly and cost effective manner.

Webinar: Performing Root Cause Analysis in Risk-based Monitoring
Risk assessment and risk management are the two important aspects of risk-based monitoring. Effective risk action planning involves effective.


Webinar: Use Of Digital & Social Media In Patient Recruitment & Retention
Digital and social media offer powerful, cost-effective tools for patient recruitment and retention in clinical trials.

Webinar: Digital and social media offer powerful, cost-effective tools for patient recruitment and retention in clinical trials.
In order to maximize benefits of Risk Based Monitoring (RBM), the drug / device development companies, CROs are actively looking into implementation of it into practice.

Webinar Part I: Risk-Based Monitoring: A Pathway to Efficient Quality Management
After issuance of the guidance document by FDA on – 'A Risk Based Approach to Monitoring' and EMA Reflection Paper on – Risk Based Quality Management in Clinical Trials.

Webinar: Patient Enrollment In Oncology Clinical Trials Challenges & Best Solutions
Webinar - Patient Enrollment In Oncology Clinical Trials Challenges & Best Solutions.

Webinar: Managing Global Submissions with Lean Regulatory Teams
RAPS and MakroCare are holding a webcast on "Managing Global Submissions with Lean Regulatory Teams".


Webinar: Clinical Research in Emerging Regions: Understanding Challenges & Best Practices
The emerging regions such as Latin America (LA), Central & Eastern Europe(CEE) and Asia Pacific (APAC) play very important role in global clinical research.

Webinar: Need for Data Integration in eClinical systems
As eClinical tools continue to gain popularity throughout the drug development spectrum, there is increasing access to more real-time data to multiple stakeholders in a clinical study.

Webinar: GCP in China/Korea/India – Commonalities/Differences
Asia is a diverse place with diverse population and diverse economies. Growing number of clinical trials in Asia means continuous learning and education.

Webinar: Clinical Trials : Asia-Pacific Perspective
The Asia Pacific region is a dynamic emerging market with two of the world’s largest populations; India with 1.2 billion and China with another 1.3 billion. According to

Webinar: Impact on Medical Affairs from Global Growth & Increased competition
Today in this ever changing and challenging healthcare environment medical affairs plays an important role in providing medical and scientific perspectives for company's brands.


Webinar: Patient Recruitment & Retention – Challenges & Best Practices
Patient optimization, recruitment and retention, a key determinant of the success of a clinical trial, has always been a challenge.

Webinar: CNS Clinical Research challenges on 15th Oct,2010
PACE is bringing together industry and academicians to explore the current and future opportunities within Clinical research in CNS

Webinar: Computer System Validation
MakroCare Consulting organizing an Interactive Webinar on “Best practices – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5)”