North Carolina Regulatory Affairs Forum

2021 RAC Workshop Syllabus

Pharmaceuticals and Biologics Medical Devices and In Vitro Diagnostics

Date Lecture & Suggested Book Chapters Lecturer Lecturer Lecture & Suggested Book Chapters
1-Jun Introduction David Kevin Barber Introduction
Sect.I-Chapter 1 History of Food, Drug and Shoemaker Sect.I-Chapter 1 History of Food, Drug and
Cosmetic Laws Cosmetic Laws
Sect.I-Chapter 2 Overview of Drug, Biologic, Sect.I-Chapter 2 Overview of Drug, Biologic, Device,
Device, Combination Product or Food Regulatory Combination Product or Food Regulatory Pathways
Pathways Sect.I-Chapter 3 Clinical Trials: GCPs, Regulations
Sect.II-Chapter 1 Health Canada Organization and Compliance for Drugs, Biologics and Medical
and Its History of Regulating Health Products in Devices
Canada Sect.II-Chapter 1 The New Medical Device
Sect.III-Chapter 1 Overview of Drug and Biologic Regulation and In Vitro Diagnostic Device
Regulatory Pathways Regulation
Sect.IV-Chapter 1 Clinical Trials, Good Clinical Sect.II-Chapter 2 The European Medical Devices
Practice, Regulations and Compliance Legal System
Sect.II-Chapter 3 Medical Devices: Legislation and
Classification
Sect.IV-Chapter 1 Health Canada
8-Jun Clinical Development and GCPs Liz Moore Clinical Development and GCPs
Sect.I-Chapter 3 Clinical Trials: GCPs, Regulations Sect.I-Chapter 3 Clinical Trials: GCPs, Regulations
and Compliance for Drugs, Biologics and Medical and Compliance for Drugs, Biologics and Medical
Devices Devices
Sect.II-Chapter 3 Clinical Trial Applications, Good Sect.II-Chapter 7 Clinical Evaluation and Clinical
Clinical Practices Investigations
Sect.III-Chapter 5 Medicinal Product Clinical Sect.IV-Chapter 2 Investigational Testing and
Trials Special Access Programme
Sect.IV-Chapter 1 Clinical Trials, Good Clinical
Practice, Regulations and Compliance
15-Jun Preclinical Development and GLPs Brenda Faiola Preclinical Development and GLPs (Device
Sect.II-Chapter 2 Good Laboratory Practice for biocompatibility)
Nonclinical Laboratory Studies Sect.II-Chapter 6 Medical Device Preclinical Testing
Sect.III-Chapter 4 Preclinical Testing and Good
Laboratory Practices
 Pharmaceuticals and Biologics Medical Devices and In Vitro Diagnostics
Date Lecture & Suggested Book Chapters Lecturer Lecturer Lecture & Suggested Book Chapters
22-Jun CMC/Quality System Design & Development Scott Burian CMC/Quality System Design & Development
Sect.I-Chapter 4 Current Good Manufacturing Sect.I-Chapter 4 Current Good Manufacturing
Practices and Quality System Design Practices and Quality System Design
Sect.II-Chapter 4 Good Manufacturing Practices Sect.II-Chapter 5 General Safety and Performance
and Establishment Licensing in Canada Requirements and Technical Documentation
Sect.III-Chapter 7 Quality Systems and Sect.III-Chapter 3 Device Quality Systems
Inspectorate Process - Pharmaceuticals Sect.IV-Chapter 5 Medical Device Quality System
Sect.IV-Chapter 5 Stability Test Requirements Requirements
Sect.IV-Chapter 6 Quality Systems and Sect IV-Chapter 9 Medical Device Establishment
Inspectorate Process for Pharmaceuticals Licensing
29-Jun Compliance, Regulatory Inspections, and Sandy Kennedy Compliance, Regulatory Inspections, and
Enforcement Enforcement
Sect.I-Chapter 2 Overview of Drug, Biologic, Sect.I-Chapter 2 Overview of Drug, Biologic, Device,
Device, Combination Product or Food Regulatory Combination Product or Food Regulatory Pathways
Pathways Sect.I-Chapter 3 Clinical Trials: GCPs, Sect.I-Chapter 3 Clinical Trials: GCPs, Regulations
Regulations and Compliance for Drugs, Biologics and Compliance for Drugs, Biologics and Medical
and Medical Devices Devices
Sect.I-Chapter 6 Postapproval Submissions and Sect.I-Chapter 5 Medical Device Submissions
Compliance: Prescription Drugs and Biologics Sect.II-Chapter 8 Medical Device Conformity
Sect.I-Chapter 13 Biologics Compliance Assessment Procedure
Sect.III-Chapter 7 Quality Systems and Sect.II-Chapter 9 Medical Device Compliance:
Inspectorate Process - Pharmaceuticals Postmarket Requirements
Sect.IV-Chapter 6 Quality Systems and Sect.III-Chapter 3 Device Quality Systems
Inspectorate Process for Pharmaceuticals Sect.IV-Chapter 5 Medical Device Quality System
Requirements
6-Jul Clinical Pharmacology Mark Cheng Medical Device Design Process (Design
Shelton Li Controls)
Sect.I-Chapter 4 Current Good Manufacturing
Practices and Quality System Design
Sect.II-Chapter 5 General Safety and Performance
Requirements and Technical Documentation
Sect.III-Chapter 3 Device Quality Systems
Sect.IV-Chapter 5 Medical Device Quality System
Requirements
 Pharmaceuticals and Biologics Medical Devices and In Vitro Diagnostics
Date Lecture & Suggested Book Chapters Lecturer Lecturer Lecture & Suggested Book Chapters
13-Jul Biologics and Biosimilars Charity David Jensen IDEs, etc (ex-US device clinical trial
Sect.I-Chapter 12 Biologics Submissions Schuller submissions)
Sect.I-Chapter 14 Biosimilars Sect.I-Chapter 5 Medical Device Submissions
Sect. II-Chapter 11 Biologics Submission, Sect.II-Chapter 7 Clinical Evaluation and Clinical
Approval and Postmarketing Investigations
Sect.III-Chapter 10 Marketing Authorisations for Sect.III-Chapter 2 Technical and Regulatory
Products Derived From Biotechnology Requirements
Sect.IV-Chapter 10 High-Risk Products Derived Sect.IV-Chapter 2 Investigational Testing and
from Biotechnology Special Access Programme
Sect.IV-Chapter 11 Biosimilars: Basics and Recent
Developments
Sect.IV-Chapter 12 Vaccines
Sect.IV-Chapter 13 Products Manufactured from
Human Blood and Plasma
20-Jul Regulatory Authority Meetings Kevin Barber Regulatory Authority Meetings
Sect.I-Chapter 2 Overview of Drug, Biologic, Sect.I-Chapter 5 Medical Device Submissions
Device, Combination Product or Food Regulatory
Pathways
Sect.I-Chapter 12 Biologics Submissions
Sect.II-Chapter 3 Clinical Trial Applications, Good
Clinical Practices
Sect.II-Chapter 5 New Drug Submission Process
Sect.III-Chapter 1 Overview of Drug and Biologic
Regulatory Pathways
Sect.III-Chapter 6 Registration Procedures for
Medicinal Products
27-Jul Clinical Protocols and Clinical Development Nick Kenny, Jack Modell, Ben Clinical Protocols and Clinical Development
Plans Vaughn Plans
3-Aug Pharmaceuticals, Generics, and OTC Drugs Catherine TBD Device Classification and Regulatory Controls
Sect.I-Chapter 7 Generic Drug Submissions Maher Sect.II-Chapter 1 The New Medical Device
Sect.I-Chapter 8 Patents and Exclusivity Regulation and In Vitro Diagnostic Device
Sect.I-Chapter 9 Over-the-Counter Regulation
(Nonprescription) Drug Products Sect.II-Chapter 3 Medical Devices: Legislation and
Sect. II-Chapter 8 An Overview of Pharmaceutical Classification
Intellectual Property Protection in Canada Sect.IV- Chapter 6 Medical Device Classification
 Pharmaceuticals and Biologics Medical Devices and In Vitro Diagnostics
Date Lecture & Suggested Book Chapters Lecturer Lecturer Lecture & Suggested Book Chapters
Sect. II-Chapter 10 Nonprescription Drugs
Sect.III-Chapter 8 Generic Medicinal Products
Sect.III-Chapter 9 Nonprescription Medicinal
Products
Sect.IV-Chapter 7 Generic Drug Products
Sect.IV-Chapter 8 Over-the-Counter (OTC)
Products
10-Aug INDs, IMPDs, CTAs, & CTXs Karl Maria Oyaski In Vitro Diagnostics, “LDTs”/CLIA, Companion
Sect.I-Chapter 5 Prescription Product Drug Whitney Diagnostics
Submissions Sect.I-Chapter 7 In Vitro Diagnostics Submissions
Sect.I-Chapter 12 Biologics Submissions and Compliance
Sect.II-Chapter 3 Clinical Trial Applications, Good Sect.II-Chapter 4 In Vitro Diagnostic Medical
Clinical Practices Devices
Sect.II-Chapter 13 electronic Common Technical Sect.III-Chapter 4 In Vitro Diagnostic Medical
Document (eCTD) Devices
Sect.III-Chapter 2 Overview of Authorisation Sect.IV-Chapter 4 In Vitro Diagnostic Medical
Procedures for Medicinal Products Devices
Sect.III-Chapter 3 Adaptive and Alternative
Pathways
Sect.IV-Chapter 3 Premarket
Requirements/Dossier Requirements
17-Aug NDAs/BLAs, MAAs, JNDAs, NDSs Rob Ken Butz 510(k)s, PMAs, Canada, EU (CE mark, etc), Int.
Sect.I-Chapter 5 Prescription Product Drug Woolson & Sect.I-Chapter 5 Medical Device Submissions
Submissions David Sect.II-Chapter 8 Medical Device Conformity
Sect.I-Chapter 12 Biologics Submissions Shoemaker Assessment Procedure
Sect.II-Chapter 5 New Drug Submission Process Sect.II-Chapter 10 Medical Device National
Sect. II-Chapter 9 Abbreviated New Drug Particularities
Submissions Sect.III-Chapter 1 Medical Device Premarket
Sect. II-Chapter 11 Biologics Submission, Requirements
Approval and Postmarketing Sect.IV-Chapter 3 Medical Device Submission and
Sect. II-Chapter 13 electronic Common Technical Approval Process
Document (eCTD) Sect.IV-Chapter 9 Medical Device Establishment
Sect.III-Chapter 2 Overview of Authorisation Licensing
Procedures for Medicinal Products
 Pharmaceuticals and Biologics Medical Devices and In Vitro Diagnostics
Date Lecture & Suggested Book Chapters Lecturer Lecturer Lecture & Suggested Book Chapters
Sect.III-Chapter 3 Adaptive and Alternative
Pathways
Sect.III-Chapter 6 Registration Procedures for
Medicinal Products
Sect.IV-Chapter 4 Authorization Procedures for
Pharmaceutical Products
24-Aug Advanced Medicinal Therapeutic Products Tom Class Kevin Barber Special Programs (HDEs, Special Access, etc)
Sect.I-Chapter 5 Medical Device Submissions
Sect.II-Chapter 8 Medical Device Conformity
Assessment Procedure
Sect.II-Chapter 10 Medical Device National
Particularities
Sect.III-Chapter 1 Medical Device Premarket
Requirements
Sect.IV-Chapter 2 Investigational Testing and
Special Access Programme
Sect.IV-Chapter 3 Medical Device Submission and
Approval Process
Sect.IV-Chapter 9 Medical Device Establishment
Licensing
31-Aug Pediatric, Orphan Product and Expanded Susan TBD Medical Device Software
Access Development for Rare Diseases Watts Sect.III-Chapter 6 Software
Sect.IV-Chapter 14 Principles of Rare Diseases
and Orphan Products Development
Sect.IV-Chapter 15 Global Pediatric Drug
Development
7-Sep Combination Products TBD Combination Products
Sect.I-Chapter 2 Overview of Drug, Biologic, Sect.I-Chapter 2 Overview of Drug, Biologic, Device,
Device, Combination Product or Food Regulatory Combination Product or Food Regulatory Pathways
Pathways Sect.I-Chapter 4 Current Good Manufacturing
Sect.I-Chapter 4 Current Good Manufacturing Practices and Quality System Design
Practices and Quality System Design Sect.I-Chapter 5 Medical Device Submissions
Sect.II-Chapter 3 Medical Devices: Legislation and
Classification
 Pharmaceuticals and Biologics Medical Devices and In Vitro Diagnostics
Date Lecture & Suggested Book Chapters Lecturer Lecturer Lecture & Suggested Book Chapters
Sect.IV-Chapter 2 Investigational Testing and
Special Access Programme
14-Sep Prescription Product Labeling Diana Fordyce Prescription Product Labeling
Sect.I-Chapter 10 Prescription Drug Labeling, & Sect.I-Chapter 8 Advertising, Promotion and
Advertising and Promotion Theresa Labeling for Medical Devices and In Vitro
Sect.I-Chapter 15 Biologics Labeling, Advertising Scocca Diagnostics (IVDs)
and Promotion Sect.IV-Chapter 7 Medical Device Labelling,
Sect. II-Chapter 12 Labelling, Advertising and Advertising and Promotion
Promotion: Prescription Pharmaceutical Drugs,
Biologics and Radiopharmaceuticals
23-Sep Pharmacovigilance and Risk Management Lisa Hornick Pharmacovigilance and Risk Management
Sect.I-Chapter 11 Pharmacovigilance and Risk No chapters dealing with this topic.
Management
Sect.II-Chapter 7 Health Product Vigilance and
Risk Management
Sect.II-Chapter 14 Product Lifecycle Management
Sect.III-Chapter 12 Pharmacovigilance
28-Sep Postmarketing Karin McIntosh Richard Vincins Postmarketing
Sect.I-Chapter 6 Postapproval Submissions and & Sect.I-Chapter 6 Medical Device Compliance and
Compliance: Prescription Drugs and Biologics David Postmarketing Activities
Sect.II-Chapter 6 Postmarketing and Other Shoemaker Sect.II-Chapter 9 Medical Device Compliance:
Activities Postmarket Requirements
Sect.III-Chapter 11 Pharmaceutical Sect.III-Chapter 7 Postmarket Requirements
Postauthorization Requirements and Compliance Sect.IV-Chapter 8 Medical Device Postmarketing
with the Marketing Authorisations
Sect.IV-Chapter 2 International Advertising and
Promotion
Sect.IV-Chapter 9 Pharmaceutical Postmarketing
and Compliance

Legend:

Blue text = US (1st 4 chapters in pharmaceuticals and biologics & devices are the same)
Green text = Canada
 Red text = EU
Teal text = International

TEXTBOOKS available on the RAPS.org website:

Pharmaceuticals and Biologics:

VOL 1 Fundamentals_of_Pharmaceutical_and_Biologics_Regulations

VOL 2 Fundamentals_of_Pharmaceutical_and_Biologics_Regulations

Medical Devices and In Vitro Diagnostics:

Fundamentals_of_Medical_Device_Regulations__Second Edition