Skip to main content

Strategies for Effective Management and Oversight of Clinical Outsourcing to Ensure Regulatory Compliance

Overview

Vendor Oversight is currently a hot topic as Sponsors and vendors aim to get to grips with what is really required.  You don’t want to outsource and then expend multiple resources to manage and oversee your trial.  As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company.   What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees.  

Areas Covered in the Session

  • Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include ICH E 6 R2
  • Outsourcing models: what could work best for your organization
  • Selecting the right providers for your outsourcing model
  • What are the key components of Vendor Oversight
  • Implementing an effective Governance Structure
  • Implementing effective Vendor Oversight and Management

Learning Objectives

  • Understand the regulatory requirements that impact Vendor management and Vendor Oversight including recent revisions
  • Explore different Outsourcing Models and what they mean when implementing effective Vendor management and Oversight
  • Explain the requirements for selecting vendors to meet your outsourcing requirements
  • Describe expectations for Vendor Oversight and how to implement a practical vendor oversight plan
  • Recognise the components of vendor governances and understand what is right for your organization
  • Evaluate what makes excellent vendor management and oversight to support clinical trial delivery


Read more
Labels:

Comments

Post a Comment

Popular posts from this blog

The Proper Way to Correct I-9 Documents and Not Pay Penalties

Surprising as it might sound, many employers are either unaware of I-9 documents penalties and fines, or are willing to take the risk of noncompliance. This is a very bad situation to be in, something that has been compounded by the fact that the regulatory agencies are communicating more than ever before on this topic. The way in which the departments communicate with each other makes it easier for them to target employers. Yet, the fact is that most complaints come from disgruntled employees, while others come from audits of target industries. Moreover, the DHS developed a new I-9 Form effective from January 21, 2017, which has to be used immediately. This makes it imperative for employers to be aware of all the new guidelines for completing the new I-9 form as well as the ongoing regulations. A webinar that is being organized by Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will give proper understanding and perspective on ...
Post a Comment
Read more

Having Difficult Workplace Conversations

Good communication abilities area unit a core competence of a frontrunner or manager  among the place of labor. this is often above all true within the place of job  whereby  collaboration and cooperation area unit necessary to realize success. Having  powerful  work conversations do now not have to be compelled to be some  factor we have a tendency to turn away from. Instead, it will grow to be wont as we have a tendency to  find out how to concentrate, keep responsibility conversations and  address  powerful  behaviour of those we have a tendency topaintings with. Having the potential  to speak  effectively once handling arduous troubles is what's  wished  withinthe trendy place of labor and will set United S...
Post a Comment
Read more

Fashion industry ‘waking up’ to benefits of blockchain technology, robotics

Blockchain and robotics are becoming increasingly popular in the global fashion industry as brands look to increase transparency and improve efficiencies, according to GlobalData. While it is still in its infancy, blockchain technology has the potential to transform the global supply chain, says Michelle Russell, apparel correspondent at GlobalData. She says that during the last few years, the adoption of blockchain technology amongst apparel and textile companies has grown substantially as the pressure to have more visibility in the supply chain ramps up. “Its uses are varied as companies use the ledger to address problems in unethical behaviour, excess waste, the origin of goods, and counterfeiting.” German start-up Retraced recently launched a blockchain-based transparency solution that it is trialling with a number of fashion brands. Other examples include OpenSC which received US$4 million in seed funding for its platform that aims to build transparency around commodities know...
Post a Comment
Read more