Conférences  >  Médecine & Soins de Santé  >  Législation en médecine et pharmacologie  >  États-Unis

FDAMap

Starting or managing a clinical trial often feels like navigating a maze—from regulatory hurdles, site management, and patient recruitment to data accuracy, budget constraints, and compliance. These challenges are real, but smart trials offer breakthrough solutions by transforming each stage of your trial into an efficient, seamless experience. Imagine trials that are faster, safer, and easier to manage! With AI-driven recruitment, remote patient monitoring, and real-time data accuracy, smart trials are revolutionizing the industry.

FDA, Smart Clinical Trials, Clinical Trials, Clinical Study, Clinical Research, Clinical Development, FDA Regulations, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

ComplianceOnline

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training. To accomplish these goals, we will review regulatory agency expectations when an SOP is written, provide suggestions for uncovering the process in its entirety and describe it clearly and concisely, indicate how to break portions of the process(es) into logical chunks, and show how the SOP and the training program can work together harmoniously.

Improve the writing of SOPs for more effective training and reduction of errors and to understand the regulatory implications of what is written in an SOP, learn the parameters of an effective SOP, explore the connection between SOPs and job performance, and measure retention of SOP content at the training stage