Regulatory Affairs
First Job in Regulatory Affairs Program
Build a structured foundation in Regulatory Affairs and understand how medicines are registered, maintained and supported across their lifecycle.
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LEARNING AREA SUBSCRIPTION
Regulatory Affairs Subscription
Build your regulatory affairs expertise with access to all courses and job-ready programs in this learning area. Get the latest course versions and new courses while your subscription is active.
33.25€/month
399.00€ billed annually
Access all 36 courses in Regulatory Affairs while your subscription is active.
- Latest course versions and new courses added to the learning area
- 4 job-ready programs included
- Course certificates and job-ready certificates
Everything included in your learning area
One subscription gives you the complete current learning area and keeps it up to date while your subscription is active.
JOB-READY PROGRAMS
Job-ready programs included
Choose any program in this learning area. Each program provides a focused 10-course curriculum and a job-ready certificate after completion.
Regulatory Affairs
Regulatory Operations & Submissions Specialist Program
Focus on regulatory dossiers, CTD/eCTD structure, application documentation and the operational processes supporting regulatory submissions.
View program
Regulatory Affairs
Regulatory Product Information & Labelling Specialist Program
Focus on Product Information, labelling, mock-ups and the regulatory processes used to maintain and implement product-information changes.
View program
Regulatory Affairs
Local Regulatory Affairs Specialist Program
Build knowledge of the regulatory activities used to maintain products and support compliance at local affiliate and market level.
View programCOURSE LIBRARY
Explore all courses in this learning area
Open a course to review its content, duration and learning outcomes. Every course below is included while your subscription is active.
Courses included in this subscription
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Additional risk minimization measures
PharmacovigilanceRegulatory AffairsKarolina Smyl, Karolina Wawrzyniak
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CTD module 3 – Quality (EU). Active Pharmaceutical Ingredient (API) / Drug Substance in medicinal products for Human use
Regulatory AffairsPaweł Pawłowski -
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Dossier of authorized medicinal products in format of CTD, NeeS and eCTD
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Fees payable to Regulatory Agencies on the example of EMA and URPL in Poland
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Introduction to bioequivalence of medicinal products
Clinical TrialsRegulatory AffairsJoanna Kupidura -
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Introduction to electronic submission of documentation and Electronic Application Form
Regulatory AffairsJoanna Kupidura -
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Introduction to individual development plan
PharmacovigilanceClinical TrialsRegulatory AffairsMarcin Gołembski -
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Introduction to Module 5 of the registration dossier (Clinical study reports)
Regulatory AffairsJoanna Kupidura -
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Introduction to the activities performed by Regulatory Affairs Department
Regulatory AffairsJoanna Kupidura -
Introduction to the Marketing Authorisation application form and the basis for the eAF – Electronic Application Form
Regulatory AffairsJulita Wójcik -
Introduction to types of the procedures for registration of medicinal products
Regulatory AffairsJoanna Kupidura -
Management of Company Core Safety Information
PharmacovigilanceRegulatory AffairsJulita Wójcik, Anna Kończak -
Managing Product Information updates depending on the type of procedure
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Medicines under additional monitoring, the black triangle
PharmacovigilanceRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
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Navigating EU CTR 536/2014 with transitioning from CTD
PharmacovigilanceClinical TrialsRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
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PRAC, CHMP, CMDh – the role and responsibilities that impact on the PV activities performed by MAH
PharmacovigilanceRegulatory AffairsAndrzej CzesławskiCertified by: -
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Requirements for Product Information of medicinal products
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
What is MedDRA and how is it used?
PharmacovigilanceRegulatory AffairsAleksandra MalickaCertified by:
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Pharmacovigilance Subscription
399.00€ / YearLearning area: PharmacovigilanceSubscribe
Number of courses included: 40 -
Introduction to role of Qualified Person Responsible for Pharmacovigilance
PharmacovigilanceKatarzyna Baltyn, Anna KończakCertified by:
Courses included in this subscription
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Management of Company Core Safety Information
PharmacovigilanceRegulatory AffairsJulita Wójcik, Anna Kończak -
-
-
-
-
Introduction to Module 5 of the registration dossier (Clinical study reports)
Regulatory AffairsJoanna Kupidura -
What is MedDRA and how is it used?
PharmacovigilanceRegulatory AffairsAleksandra MalickaCertified by: -
CTD module 3 – Quality (EU). Active Pharmaceutical Ingredient (API) / Drug Substance in medicinal products for Human use
Regulatory AffairsPaweł Pawłowski -
Introduction to the Marketing Authorisation application form and the basis for the eAF – Electronic Application Form
Regulatory AffairsJulita Wójcik -
-
Requirements for Product Information of medicinal products
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Introduction to the activities performed by Regulatory Affairs Department
Regulatory AffairsJoanna Kupidura -
Medicines under additional monitoring, the black triangle
PharmacovigilanceRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
PRAC, CHMP, CMDh – the role and responsibilities that impact on the PV activities performed by MAH
PharmacovigilanceRegulatory AffairsAndrzej CzesławskiCertified by: -
-
-
-
Introduction to individual development plan
PharmacovigilanceClinical TrialsRegulatory AffairsMarcin Gołembski -
-
Additional risk minimization measures
PharmacovigilanceRegulatory AffairsKarolina Smyl, Karolina Wawrzyniak -
-
-
-
Introduction to bioequivalence of medicinal products
Clinical TrialsRegulatory AffairsJoanna Kupidura -
-
Introduction to types of the procedures for registration of medicinal products
Regulatory AffairsJoanna Kupidura -
-
Fees payable to Regulatory Agencies on the example of EMA and URPL in Poland
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Introduction to electronic submission of documentation and Electronic Application Form
Regulatory AffairsJoanna Kupidura -
-
-
Dossier of authorized medicinal products in format of CTD, NeeS and eCTD
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Managing Product Information updates depending on the type of procedure
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
-
-
Navigating EU CTR 536/2014 with transitioning from CTD
PharmacovigilanceClinical TrialsRegulatory AffairsKatarzyna Kopacz-Zakrzewska