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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

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

FDAMap

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

FDA Regulation, FDA Compliance, 510(k) Submissions

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

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,

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

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

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

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

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

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

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

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

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien