Access to data from regulatory authorities by Peter Gotzche

Introduction to case study and propose :
a: EU legislative framework
b: A reply from EMA's director
c: Timeline. 3.5years
d: EMA's Commercial interests
e: The Ombudsman on commercial interests
f: Over-reding public interest
g: The Ombudsman on over-riding public interest
h: Other arguments
i: The Ombudman on personal data
j: the European Ombydsman after a 3-year stand-off
k: Implications
Ongoing Research at our centre:
a: Experience from other drug regulators
Sharing research data:
a: Who owns trial data?
b: Reducing selective reporting
c: Benefits of data sharing
d: Harms of data sharing
e: Implications for the drug industry
Any restrictions ?
Any pratical difficulties ?
Commercial success or patient welfare ?
-Conclusion: Drug regulators have changed their views
Additional drug regulator terminology