Overview and statistics on marketing authorization procedures and drug regulations in the EU / US

The registration dossier

• Purpose
• Structure 
• Preparation 
• Electronic submission

Product Variations in the EU / US

• Statistics
• Classification

The competent authorities in the EU and US

• Organization
• Responsibilities and duties
• International cooperation between authorities

Meetings with authorities

• Categories of meetings
• Preparation of meetings
• Scientific advice 

Drug Regulatory Affairs in the pharmaceutical industry

• Goals
• Qualification and responsibilities of personel
• Organizational aspects
• Interactions with other departments within the company 

Good Regulatory Practices

• Definition
• GRP at the authorities
• GRP in the pharmaceutical industry
• Best Practice Guides
• Quality assurance in the pharmaceutical industry