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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

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

FDAMap

Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.

Clinical Project Management, Clinical Project Managers, FDA Regulations, FDA Compliance,

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung