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Regulatory Affairs for Medical Devices, Pharmaceuticals & Biologics

Fermé
Contact principal
Northeastern University
Northeastern University
Boston, Massachusetts, United States
Cara Halloran - Paquette
Partnership Development Coodinator
(7)
6
Chronologie
  • février 1, 2024
    Début de expérience
  • mai 31, 2024
    Fin de expérience
Expérience
7/7 match de projet
Dates fixées par le expérience
Entreprises privilégiées
N'importe où
Tout type de entreprise
Business & management, Hospital, health, wellness & medical, Science, Trade & international business

Portée de Expérience

Catégories
Santé Étude de marché Expansion du marché Lancement d'un produit ou d'un service Droit et politique
Compétences
regulatory affairs marketing medical devices regulatory sciences pharmaceuticals research commercialization
Objectifs et capacités de apprenant.e.s

A global, experiential, research university is seeking projects for their Master of Science in Regulatory Affairs capstone course.


The Master of Science in Regulatory Affairs program is designed to both broaden and deepen the student’s understanding of current global compliance requirements and their practical application in the design, development, approval, and post marketing of products utilized within regulated industries.


The capstone course challenges students to exercise their ability to translate global regulatory requirements for globally regulated product commercialization into submission-ready documents and broadly applicable regulatory science solutions.


This is your opportunity to connect with students and faculty from a renowned institution in New England that consistently ranks among the top universities in the United States and is known for its focus on interdisciplinary education, extensive research output, and collaborative student culture.

Apprenant.e.s

Apprenant.e.s
Finissant
Tout niveau
50 apprenant.e.s dans le programme
Projet
10 heures par apprenant.e.s
Les Pédagogues affectent les apprenant.e.s à des projets
Équipes de 4
Résultats et livrables attendus

Deliverables are negotiable, and will seek to align the needs of the students and the organization.

Some final project deliverables might include:

  1. A 10-15 minute presentation on key findings and recommendations
  2. A detailed report including their research, analysis, insights and recommendations
Chronologie du projet
  • février 1, 2024
    Début de expérience
  • mai 31, 2024
    Fin de expérience

Exemples de projets

Student teams will work with your organization to identify your needs and provide actionable recommendations, based on in-depth research and analysis.

Desired project topics include:

Strategic Regulatory Affairs

  • Classification
  • Combination Product Approvals
  • Global Commercialization

Clinical Research

  • Clinical Trial Design
  • Clinical Operations
  • Study Rationales

Regulatory Compliance

  • Adverse event profiling
  • REMS
  • Post Market Surveillance

General Regulatory Affairs

  • Regulatory Market Research

We invite you to share your projects for consideration. Please include an executive summary of the regulatory affairs problem or topic. Be sure to include a brief description of your organization and mission.