Seminar Materials
Selected Course Materials for Seminar Participants
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The documents posted here must not be used for regulatory decision making. These documents are for use in the framework of a labeling workshop where not only current but also historic documents are of interest. This means: Some of these documents are not the current versions! For regulatory decision making always refer to the most current regulations and guidelines posted on official agency websites.
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US Prescribing Information and Safety Labeling Seminar
- EU: A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS (2005)
- EU: Draft SmPC Guideline (December 2007)
- ICH HARMONISED TRIPARTITE GUIDELINE: CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING - E2A (1994)
- US Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (2006)
- US DRAFT Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics (2000)
- US Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format - DRAFT GUIDANCE (2006)
- US Guidance for Industry: Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (1997)
- US Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (1999)
- US DRAFT Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling (2006)
- US 21 CFR Parts 201, 314, and 60: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products - Final rule (2006)
- US DRAFT: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products - Proposed rule (2000)
- US DRAFT Guidance for Industry Labeling for Human Prescription Drug and Biological Products - Implementing the New Content and Format Requirements (2006)
- US Reviewer Guidance: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (2005)
- US Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (2006)
- US Guidance: Drug Safety Information – FDA’s Communication to the Public (2007)
- US DRAFT Guidance: FDA’s “Drug Watch” for Emerging Drug Safety Information (2005)
- US DRAFT Guidance for Industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (2007)
- US DRAFT Guidance - Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (2007)
- US Proposed Pregnancy and Lactation Rule (2008)
- US CBE Rule (2008)
Company Core Data Sheets and Core Safety Information Seminar
- EU: A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS (2005)
- EU: Draft SmPC Guideline (December 2007; clean)
- EU: Draft SmPC Guideline (December 2007; redlined)
- ICH HARMONISED TRIPARTITE GUIDELINE: CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING - E2A (1994)
- US Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (2006)
- US Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format - DRAFT GUIDANCE (2006)
- US Guidance for Industry: Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (1997)
- US 21 CFR Parts 201, 314, and 60: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products - Final rule (2006)
- US Reviewer Guidance: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (2005)
- US Guidance: Drug Safety Information – FDA’s Communication to the Public (2007)
- US DRAFT Guidance for Industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (2007)
- AUSTRALIA: Australian Regulatory Guidelines for Prescription Medicines - Appendix 8: Product Information
- CANADA: Guidance for Industry - Product Monograph (2004)
- SWITZERLAND: Swiss Agency for Therapeutic Products - Anforderungen an die Information für die Medizinalpersonen und den Arzneimittel-Fachhandel ("Fachinformation") (document in German)
- Australian Pregancy Catergories
- US Proposed Pregnancy and Lactation Rule
- EU Pregnancy Risk Evaluation and Labeling Guideline (2008)
- US CBE Rule (2008)
JAPAN: For copyright reasons we unable provide an electronic copy of an English version of PAB Notification No. 606 and PAB Notification No. 607. More general information on labeling and English-language examples of Japanese labels can be found at http://www.jpma.or.jp/12english/.
CIOMS Reports III/V, V, VI and VII: For copyright reasons we unable provide an electronic copy. To order reports V, VI and VII send an email to cioms@who.int. The CIOMS III/V report is out of print; an electronic copy can be found in IDRAC.