Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development
Dr Laura Brown is an independent pharmaceutical QA and training consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff. Laura is an expert in outsourcing pharmaceutical research projects including CRO selection, audit and management. She has more than 20 years' experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International in outsourcing pharmaceutical projects. She has worked in several vendor selection and management roles which have included reviewing quality and performance of CROs and has advised companies on how to implement quality systems for CRO selection and management.
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Recorded Webinar
Risk Based Clinical Trial Monitoring
This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
Recorded Session Get life time access for one participant with download option!

EU GDPR Deadline is Just around the Corner: Understanding Compliance for Clinical Trials for Life Sciences Companies
The General Data Protection Regulation (GDPR) is new legislation that comes into force on 25th of May 2018 which brings substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organizations that hold and process personal data such as clinical trial data, with regulators poised to impose much heavier fines for noncompliance-in the most serious cases as high as €20m or four percent of worldwide turnover.
Recorded Session Get life time access for one participant with download option!

General Data Protection Regulation (GDPR): Compliance for Clinical Trials
The General Data Protection Regulation (GDPR) is new legislation that comes into force on 25th of May 2018 which brings substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organizations that hold and process personal data such as clinical trial data.
Recorded Session Get life time access for one participant with download option!

Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial Quality
CROs and sponsors serious about driving clinical trial quality, efficiency, and oversight, are aware of the FDA guidance: "A Risk-Based Approach to Monitoring." From a practical level, how do you start your program and gain the full advantages of RBM? This course will provide opportunities to practice the necessary skills to apply a risk based approach to monitoring activities. This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
Recorded Session Get life time access for one participant with download option!

CRO Oversight: Practicalities, Roles and Responsibilities Discussion
Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors. Every process - from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation - requires a high degree of risk-based diligence to satisfy regulators.
Recorded Session Get life time access for one participant with download option!

Risk Management in Clinical Trials: What will inspectors look for?
Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP guideline, recently released EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.
Recorded Session Get life time access for one participant with download option!

Risk Based Monitoring for GCP Compliance
This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
Recorded Session Get life time access for one participant with download option!

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