Π£ Π½Π°Ρ Π²Ρ ΠΌΠΎΠΆΠ΅ΡΠ΅ ΠΏΠΎΡΠΌΠΎΡΡΠ΅ΡΡ Π±Π΅ΡΠΏΠ»Π°ΡΠ½ΠΎ Access to data from regulatory authorities by Peter Gotzche ΠΈΠ»ΠΈ ΡΠΊΠ°ΡΠ°ΡΡ Π² ΠΌΠ°ΠΊΡΠΈΠΌΠ°Π»ΡΠ½ΠΎΠΌ Π΄ΠΎΡΡΡΠΏΠ½ΠΎΠΌ ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅, Π²ΠΈΠ΄Π΅ΠΎ ΠΊΠΎΡΠΎΡΠΎΠ΅ Π±ΡΠ»ΠΎ Π·Π°Π³ΡΡΠΆΠ΅Π½ΠΎ Π½Π° ΡΡΡΠ±. ΠΠ»Ρ Π·Π°Π³ΡΡΠ·ΠΊΠΈ Π²ΡΠ±Π΅ΡΠΈΡΠ΅ Π²Π°ΡΠΈΠ°Π½Ρ ΠΈΠ· ΡΠΎΡΠΌΡ Π½ΠΈΠΆΠ΅:
ΠΡΠ»ΠΈ ΠΊΠ½ΠΎΠΏΠΊΠΈ ΡΠΊΠ°ΡΠΈΠ²Π°Π½ΠΈΡ Π½Π΅
Π·Π°Π³ΡΡΠ·ΠΈΠ»ΠΈΡΡ
ΠΠΠΠΠΠ’Π ΠΠΠΠ‘Π¬ ΠΈΠ»ΠΈ ΠΎΠ±Π½ΠΎΠ²ΠΈΡΠ΅ ΡΡΡΠ°Π½ΠΈΡΡ
ΠΡΠ»ΠΈ Π²ΠΎΠ·Π½ΠΈΠΊΠ°ΡΡ ΠΏΡΠΎΠ±Π»Π΅ΠΌΡ ΡΠΎ ΡΠΊΠ°ΡΠΈΠ²Π°Π½ΠΈΠ΅ΠΌ Π²ΠΈΠ΄Π΅ΠΎ, ΠΏΠΎΠΆΠ°Π»ΡΠΉΡΡΠ° Π½Π°ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ ΠΏΠΎ Π°Π΄ΡΠ΅ΡΡ Π²Π½ΠΈΠ·Ρ
ΡΡΡΠ°Π½ΠΈΡΡ.
Π‘ΠΏΠ°ΡΠΈΠ±ΠΎ Π·Π° ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΠ΅ΡΠ²ΠΈΡΠ° ClipSaver.ru
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