Pharmaceutical Research Documents

Investigational Medicinal Product Dossier (IMPD) & Investigational New Drug (IND)

• The IMPD is critical for clinical trial applications, ensuring regulatory compliance.
• IND applications are necessary for conducting clinical investigations on new drugs in the U.S.

Common Technical Document (CTD)

• CTD serves as a standardized document format for regulatory submissions.
• Comprises modules detailing objectives, plans, indications, and methodologies of clinical trials.

Institutional Review Board (IRB)

• IRBs protect rights and welfare of human research subjects within affiliated institutions.
• Regulations under 21 CFR 56 guide IRB functions, ensuring ethical research practices.

Drug Regulation

• Regulated by international agreements and authorities like FDA and EMA.
• Involves oversight of drug lifecycle from development to marketing and addresses benefit–risk assessment.

Drug Evaluation Complexity

• Drug regulators must navigate extensive evidence and balance benefits against risks.
• Additional factors such as disease severity and clinical need complicate evaluation processes.

Role of Regulatory Affairs

• Focused on human health protection by assuring drug safety, efficacy, and quality.
• Regulatory strategies depend on effective interpretation and communication of regulations.

European Medicines Agency (EMA)

• EMA supervises the evaluation and regulation of medicinal products in the EU.
• Protocol waivers and amendments are permissible under certain conditions, yet their implementation varies by classification.

Investigational Product Labeling (U.S. & EU)

• In the U.S., labels must indicate investigational status as per federal law.
• In the EU, labeling must meet Annex 13 of EU Directive 2001/83/EC and comply with local language requirements.

Investigational Product Requirements (EU)

• Sponsors must retain IMP batch records for at least five years post-trial completion.
• Sufficient samples of investigational products and components must be held for at least two years after study conclusions.

Adverse Event Reporting (U.S.)

• Critical for monitoring drug safety with regulatory requirements governing submission and management.
• Specific guidelines dictate the processes for reporting adverse events related to investigational products.

This quiz covers the Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND), and Common Technical Document (CTD) used in drug/clinical research. It tests knowledge on the objectives, rationale, and general approach of evaluating therapeutic products.