PTI - international

Agenda: Day One

I. Explore the European Regulatory Environment

• Introduce the European Union and its regulatory institutions
• Analyze EU legislation governing drug products (directives, regulations and guidelines)
• Outline regulatory decision making in the EU
• Examine the roles of the European Agency for the Evaluation of Medicinal Products (EMEA) and the Committee for Propriertary Medicinal Products (CPMP)
• Summarize the goals of the International Council on Harmonization (ICH)

Discussion: Compare and Review Participants' Backgrounds and Experiences with European Drug Approval Processes

II. Conduct Clinical Trials in the European Union

• Analyze the EU's Clinical Trial Directive
• Describe the EU's scientific advisory process
• Examine how to set up and conduct trials in the EU
• Assess HIPAA and the EU Privacy Directive

Exercise: Outline How a Company Would Conduct a Clinical Trial for the Same Product in Both the US and Europe

III. Examine the Centralized Procedure

• Outline the evolution of the Centralized Procedure
• Determine when and why to use the Centralized Procedure
• Describe the role of the EMEA project manager
• Address the selection and role of a Rapporteur
• Examine types of products with Part A or Part B status
• Discuss paument of fees to the EMEA

IV. Outline Centralized CTD Submission and Approval Procedures

• Explore regulatory planning from time of submission to approval

• Fulfill all EU dossier submission requirements
• Follow procedures for submitting a CTD
• Prepare a Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL)
• Discuss pre-approval inspections, preliminary assessments and consolidated assessments
• Know what to expect at an oral explanation meeting

Excercise: Highlight Differences Between the EU Centralized Procedure and US Approval Processes