Risk-Based Monitoring

1. Why implement Risk-Based Monitoring?
2. What is Risk-Based Monitoring?
3. Advantages of Risk-Based Monitoring over "Classic" monitoring

Regulatory - USA specific

1. How Do I Register Clinical Trials with The FDA?
2. When must a FDA 1572 form be updated?
3. Who must be listed on the FD1572 as a Subinvestigator and what activities must the Investigator do to meet his/her obligations on the FD1572?

Regulatory - EU specific

1. How Do I Register Clinical Trials with The EMA (European Medicines Agency)?
2. What are the labelling requirements for clinical trial supplies?
3. Why is only one drug product named on the Clinical Trial Authorisation approval letter for trials involving more than one investigational medicinal product?
4. Where can I find contact information for the Competent Authorities in Europe?
5. Which of the Ethical Committees and Competent Authorities assesses which parts of the Clinical Trial Application (CTA) in the EMA member states?
6. What are the requirements for the legal representative of a non EU/EEA-sponsor in view of Article 19 of Directive 2001/20/EC?
7. Can a sponsor established in a third country open a subsidiary or branch in a EMA Member State to comply with the requirement of Directive 2001/20/EC that the sponsor or a legal representative of the sponsor must be established in the EU?