Best Practices of Drug Development & Safety, Clinical Trials & Clinical Research - Training for Quality Assurance

Quality assurance and Quality control professionals play an integral part in drug development. Maintaining quality throughout the phases of product development is a continuous activity.

You must ensure that the study is conducted as per protocols with standard operating procedures (SOP) in place, and Good Clinical Practice (GCP) followed. It is required to fix systemic issues before the trial's conclusion. All of these will assist in the reduction of data queries. You must provide ideas to reduce cycle time in processes, ascertain the data's legitimacy and dependability, ensure that all data entered throughout the trial is consistent and accurate which plays a significant role in dealing with nonconformity.

Noncompliance can result in failures, delays, undetected adverse events, and, most critically, a loss of protocol and data integrity, that could lead to regulatory authorities challenging the clinical trial results.

ComplianceOnline has engaged exceptional subject matter experts to equip you and your team with a well-rounded education in the quality aspects of drug development through the following training bundle. This training is ideal for both new and experienced quality professionals.

Check out what's included in the training package

Pharmacokinetic Principles in Preclinical Safety Assessment
Applying Quality Systems Concepts to Clinical Research Activities
Clinical Research GCP training Course
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
Creating a Product Safety Program that is as Nimble as the New Product Development Program
EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development
Fraud in Clinical Research
Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

Pharmacokinetic Principles in Preclinical Safety Assessment

This webinar will describe the basic principles of pharmacokinetics, with specific emphasis on issues that can impact toxicokinetics in preclinical safety assessment studies. It will highlight methods for the optimization of physicochemical properties in the discovery and development of oral drug candidates and explore some of the preclinical methods used to select first in human (FIH) doses.

Areas Covered in the Webinar:

• Pharmacokinetic principles (ADME):
• Absorption
• Distribution
• Metabolism
• Excretion
• Understanding clearance, volume of distribution and half life.
• What properties must be optimized to improve the pharmacokinetic profile of a new drug candidate.
• Balancing solubility and permeability.
• Which pharmacokinetic parameters associate with drug safety.
• Methods to achieve sufficient drug exposures during safety assessment studies.
• Predicting human doses and exposures.

Applying Quality Systems Concepts to Clinical Research Activities

This webinar will help you identify key concepts from the US FDA Quality System Regulation (QSR - 21 CFR Part 820) that are applicable in the clinical arena, and show how you can build them into your clinical research activities.

Areas Covered in the Webinar:

• Brief overview of Quality System Regulation in the US (21 CFR Part 820).
• Risk Management.
• Quality Control versus Quality Assurance.
• Vendor (Research Site) Qualification.
• Protocol Development Considerations.
• Training Documentation.
• Monitoring Activities.
• CAPA concepts.

Clinical Research GCP training Course

This full day GCP training course will provide comprehensive learning on the Good Clinical Practices of Research involving human subjects. It will cover all key areas including recruiting study subjects, the Informed Consent process, Adverse Event Reporting and preventing protocol deviations.

Areas Covered in the Webinar:

• How to get your PI more involved in the Clinical Research process.
• Have a good plan for recruiting study subjects to eliminate the risk of failure.
• Are your Informed Consents in compliance with the new FDA Regulations – an update of the Informed Consent process
• Why is Accurate Adverse Event Reporting essential for drug safety - How to Assess and report AEs and SAEs
• How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

This webinar will show how one can develop a mechanism for providing feedback from QA to enhance education and training of their investigators and coordinators. If you belong to a site, or work with a site, that relies on external sources - monitoring visits, IRB review, FDA audit, etc. - for evaluation and feedback, then your site will benefit from this training.

Areas Covered in the Webinar:

• Elements of Quality Assurance Program.
• Elements of Monitoring.
• Elements of Auditing.
• Roles and responsibilities of study team members.
• Training and Education requirements.
• Implementing change.

Creating a Product Safety Program that is as Nimble as the New Product Development Program

This seminar on product safety provides an overview of the topic, examines how product safety can fit into a stage gate new product development process, and provides recommendations and examples on how to make product safety become an integral part of the new product development process.

Areas Covered in the Webinar:

• Overview of product safety
• US laws and codes
• US standards
• Inserting product safety into a stage gate new product development process Determining product safety requirements
• Codes and standards
• Best engineering practice
• Research
• Integrating product safety into the product development program
• Creation of a product safety team
• Developing product safety goals
• Checklists, notes & other documentation
• Verification & validation of product safety
• Development of a lessons learned database

EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development

This webinar will discuss the new GDPR regulation requirements in the context of clinical trial data, how it applies to clinical trials and pharma industry, the personal data types including clinical trial data, what are the rights of clinical trials subjects, data access requests, informed consent, how to transfer clinical trial data outside EU, data breach reporting, penalties and how to put a data governance program and process to comply with GDPR regulations.

Areas Covered in the Webinar:

• Essential overview and background of the EU General Data Protection Regulation (GDPR)
• Understand how it will apply to clinical trials and the pharma industry
• Special Categories of Personal Data includes clinical trial data
• The Rights Of clinical trial Subjects, Including Data Access Requests, informed consent
• Controllers & Processors
• Reporting Data Breaches
• The Role of The Data Protection Officer (DPO)
• Transferring clinical trial Data Outside The EU
• Penalties
• Considerations for governance to comply with the GDPR requirements

Fraud in Clinical Research

This training program will instruct you to better understand ethical and legal requirements when conducting medical/clinical research and study. The webinar will focus on what/how to identify, address and prevent fraud in medical research.

Areas Covered in the Webinar:

• Laws and Regulations
• Regulatory Requirements
• Code of Conduct for Medical Research
• Recent Fraud Cases in Medical/Clinical Research/Clinical Trials
• Duties, Responsibilities and Roles of the Stakeholders including FDA
• Motives for Fraud
• Recent Deadly-Ego Driven Games
• Deadly Corruption in Clinical Research
• How to Address Fraud in Medical/Clinical Research
• How to Prevent Fraud
• PASS-IT Recommendations

Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

This pharmacovigilance webinar will provide attendees an understanding of post-marketing drug safety surveillance, its role in lifecycle management, and the practices and regulations governing its conduct. It will describe the structure of the pharmacovigilance world including the ICH, the FDA, CIOMS, MHW, and EudraVigilance.

Areas Covered in the Webinar:

• Structure of pharmacovigilance community (ICH/CIOMS/EudraVigilance/FDA/etc.).
• Collection and analysis of post-marketing approval safety data.
• Key guidance documents and regulations.
• Notable reference documents.
• Roles and responsibilities in post-marketing development pharmacovigilance.
• Key regulatory post-marketing approval safety reports.