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Drug Development Executive Certification

CPE Credits: 13.5

Our exclusive program thoroughly explores the commercial, regulatory, and scientific factors crucial for a successful drug launch. Securing this industry-recognized Executive Certification will not only distinguish you in your current role but may also unlock new career opportunities and growth. To earn your Drug Development Executive Certification, you’ll need to successfully complete twelve Continuing Professional Education (CPE) courses and pass a final exam. By doing so, you’ll position yourself as the preferred candidate. Don’t miss out on this exclusive opportunity to enhance your career—reserve your spot today!

Course 1: Biopharma Business Acumen Primer

Provides a comprehensive understanding of the business considerations needed to develop and bring a life-saving cure to the marketplace.

CPE Credit: 1.0

Course 2: Small Molecule Drug Discovery Primer 101

Teaches the essential steps to finding and bringing new small molecule compounds to market.

CPE Credit: 1.0

Course 3: Small Molecule Drug Discovery Primer 201

Uncovers the crucial criteria for transitioning from discovery to development, including how to rigorously evaluate data from in silico, in vitro, and in vivo assets.

CPE Credit: 1.5

Course 4: Drug Discovery of Biologics Primer 101

Explains the drug discovery process, spanning target identification and verification to candidate identification, validation, and optimization.

CPE Credit: 1.0

Five Takeaways

  1. Acquire a foundational understanding of the drug discovery process for small and large molecules.
  2. List the crucial steps and tests involved in preclinical development and state the purpose of each.
  3. Gain insight into the intricacies
    of filing an IND, CTA, NDA, BLA, or MAA and explore the criteria for various expedited drug approval pathways.
  4. Enumerate the clinical trial phases in order, explain the purpose of each stage, and list their milestones.
  5. Outline and discuss the different methods employed by biopharmaceutical companies to prolong the lifecycle of a drug.

Course 5: Drug Discovery of Biologics Primer 201

Showcases the significance of four therapeutic antibody classes, emphasizing the factors that influences early drug candidate selection.

CPE Credit: 1.0

Course 6: Preclinical Development Primer 101

Walks through the essential steps of early-stage drug development and the efficacy and safety standards that must be met prior to beginning clinical trials.

CPE Credit: 1.5

Course 7: Preclinical Development Primer 201

Utilizes real-world examples and case studies to delve deep into the specific tests and data required to file a successful Investigational New Drug (IND) application.

CPE Credit: 1.0

Course 8: Drug Approval Primer

Offers a comprehensive overview of how small molecule drugs and biologics receive the regulatory green light for human use.

CPE Credit: 1.0

Course 9: Clinical Development 101: General Principles

Covers the essential study designs, regualtory milestones, and endpoint considerations needed to understand the clinical development process.

CPE Credit: 1.0

Course 10: Clinical Development 201: Phase I

Provides insights into Phase 0 and Phase I clinical trials, including their purpose and regulatory requirements.

CPE Credit: 1.0

Course 11: Clinical Development 301: Phase II/III

Focuses on the purpose and critical differences between well-controlled Phase II and III studies.

CPE Credit: 1.5

Course 12: Clinical Development 401: Phase IV

Delves into the post-approval phase of a new drug as it enters the market, highlighting the role played by regulatory agencies in safeguarding public health through the monitoring of all drugs’ pharmacovigilance in real-world scenarios.

CPE Credit: 1.0

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates
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