Pharmaceutical Regulatory Affairs

5/5
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regulatory affairs

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :ย 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

The Regulatory Affairs (RA) is a department in pharmaceutical organizations which acquires approval for marketing new pharmaceutical products from relevant regulatory authorities. It also ensures that the approval is maintained for as long as the firm wants to keep the approved product on the market. Together, regulatory authorities and regulatory affairs division work towards a common goal of ensuring that patients get new and better medical treatments while demonstrating the highest level of safety and efficacy.

In this online course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

 

Introduction

 

 

Lesson 1: The importance of regulatory affairs

 

Lesson 2: Understanding the drug development process

 

Lesson 3: What are the National and International Regulatory Authorities?

 

Lesson 4: Regulatory Process for Drug Approval & Registration

 

  • Regulatory Affairs in the US
  • Applications for Regulatory Approval in the US
  • New drug application
  • Regulatory Affairs in the EU
  • Regulatory Approval Process in the EU
  • Dossier Submission Application

 

Conclusion

 

Glossary

 

Quiz

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards.

Reviews:

5/5
24
USD: United States (US) dollar ($)

$48.00 $60

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