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Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA

Certification Training
 
Rated 4.20/5
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Program/Course ID: GCP007
Enrollment Period: 6 months.
Average Learning Time: ~180 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 3 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $225.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Description:
Biopharma Institute Reviews

The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational drug. This online course will give students who are, or are becoming, regulatory professionals the necessary detail and background required in order to complete and submit, for FDA approval, an IND application. An IND must contain various pieces of information covering areas such as clinical protocol, manufacturing, toxicology, drug distribution, and animal pharmacology. The application is a stepping stone that is crucial, from nonclinical all the way to clinical testing.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


Outline:


Module overview
An outline of the module's scope and objectives, and notes on terminology.

Introduction to Investigational New Drug Applications (INDs)
This session explains the role and legal status of an IND, sets out the contexts in which one must be filed, summarizes the responsibilities of sponsors and investigators, and outlines the pre-submission process.

IND content and format requirements
This session sets out IND contents required by regulations and describes how these are incorporated in a CTD-formatted submission. The significance of the FDA forms 1571 and 1572 are discussed. The major components of an application are outlined: general investigational plan, investigator's brochure, clinical protocol, Quality/CMC information, nonclinical data, and clinical information.

Filing and FDA review
Options and requirements for submission of an IND are set out, and the review procedure and its outcomes are described. The roles of FDA reviewers are outlined. The significance of a clinical hold and the sponsor's response to a hold are discussed.

Maintenance of an IND
This session identifies the various types of IND amendments and reports: protocol amendments, IND safety reports, annual reports, and information amendments. It explains when they need to be made and outlines the regulations that govern them. The responsibilities of sponsors and investigators to report safety findings are described, as are requirements for financial disclosure and record retention.

Expanded-access use
This session describes the various types of expanded-access use of investigational drugs to treat patients outside of clinical trials and sketches a scenario of emergency use.

Assessment
Multiple-choice mastery assessment.

Objectives:


Who will benefit from this module?
  • Regulatory affairs professionals and other staff of pharmaceutical or biotechnology companies involved in clinical development of medicinal products; and
  • Healthcare professionals conducting clinical research as sponsor-investigators or who wish to treat patients under an expanded-access scheme.
Learning objectives
  • Specify the role of an IND and the contexts in which it is required
  • Access key regulatory documents relating to INDs
  • Describe the contents and format of an IND submission
  • Describe the process of FDA review of an IND, the possible outcomes and sponsor's responses
  • Identify actions necessary to maintain an active IND
  • Specify options for expanded-access use of investigational drugs

Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA is included in the following professional certification programs:



Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Price: $1295.00 (USD) | Learn more

Training Program For Professionals:

Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals

Course ID: GCP00A2
Price: $895.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.