About Zenosis
Benefits of Zenosis
Zenosis Regulatory Affairs & Compliance
SUB01: Orphan Drug Applications in the EU and USA
SUB02: The European Centralised Procedure (CP)
SUB03: The Mutual Recognition Procedure (MRP)
SUB04: Preparing Submissions in the Common Technical Document (CTD) Format
SUB05: Electronic Common Technical Document (eCTD)
SUB06: Variations to Marketing Authorisations in Europe
SUB07: Registration of Monoclonal Antibodies
SUB08: The ANDA: Requirements for Obtaining Approval for a Generic Product in the USA
SUB09: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
SUB11: The Decentralised Procedure (DCP)
ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
CT01: How to Obtain Approval to Conduct Clinical Trials in the EU
CT10: The IND: How to Gain Approval for Clinical Trials in the USA
Zenosis Clinical Trials
CT03: An Introduction to ICH Good Clinical Practice (ICHJ-GCP)
CT04: An Introduction to Clinical Trial Preparation and Design
CT05: An Introduction to Clinical Trials in India
CT06: Clinical Trial Monitoring: Site Evaluation and Setup
CT07: Introduction to Clinical Trials and Drug Development
CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
CT09: Preparing for a GCP Audit or Inspection
SC01: Pharmacokinetics and Pharmacodynamics in Drug Registration
CT01: How to Obtain Approval to Conduct Clinical Trials in the EU
CT10: The IND: How to Gain Approval for Clinical Trials in the USA
GMP/CMC
Drug Safety & Pharmacovigilance
Request a Zenosis Trial
Zenosis Terms & Conditions
Pathways Summary
ESS01Essentials of EU and US Regulatory Affairs for Human Medicinal Products
This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. When changes to regulations and procedures occur, the module is updated and hence serves as a handy reference tool allowing new as well as experienced users to keep up to date with the broader picture of the regulatory affairs environment.
Approximate Course Time: 3 hours
Level: Foundation
Audience: Regulatory
Category: Preclinical, Clinical, Pharmacovigilance, Manufactoring and QC, IT, Regulatory Submissions, Commercial, Chemistry and Pharmacy
Region: USA, Europe
Who will benefit from this module?
All staff in the pharmaceutical industry who are inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course. More experienced personnel will find it a useful reference tool.
Learning objectives
- Describe the role and responsibilities of regulatory affairs within the pharmaceutical industry in both the EU and the USA.
- Identify the main legislative instruments relating to medicinal products in both the EU and USA.
- Understand the main phases of the drug development process and be aware of the regulatory requirements that apply.
- Describe the requirements for applications for marketing approval and the procedures to be followed in both the EU and USA.
- Identify post-marketing regulatory activities in both the EU and USA.
Course Outline
Regulatory affairs primer – This session gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU.
The life-cycle of a drug – This session looks at the main differences between types of medicinal products, outlines the discovery phase and nonclinical studies and gives a basic introduction to Good Laboratory Practice. It also identifies the four phases of clinical development and introduces some of the special difficulties associated with paediatric trials.
Registering a drug – This session looks at the regulatory requirements during the nonclinical studies phase as well as the salient points of Good Clinical Practice. It also introduces the regulatory processes involved in gaining marketing authorisation in the EU and the USA. The session also introduces the learner to orphan drugs, line extensions, generics, naming conventions and compassionate use.
After marketing approval – This session explores post-marketing approval activities, including variations and supplements, line extensions and pharmacovigilance, GMP, basic patent law in the EU and USA, marketing issues, advertising and generics.
Assessment – Multiple-choice mastery assessment.