Αποτελέσματα Αναζήτησης
All activities with a due date shall be due at 23:59:59 on that day, according to the specified time zone. o Working day due date: The due date must fall on a working day. o Two consecutive working days: There must be a minimum of two consecutive working days at any time during the task timer. o Winter Clock stop:
- Clear maximum timelines set in calendar days resulting in tacit decision (article 8.6, CTR) or application lapse if not adhered to. - Relevant notifications to CTIS to document the status of the CT conduct and the safety surveillance activity by sponsor. - Clinical trials with vulnerable subjects should comply with specific requirements4.
See the full list of procedural timetables below: The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants and marketing-authorisation holders (MAHs).
12 Μαρ 2023 · The validation period between submission date and start date is 13 EMA working days. Please observe the EMA procedural timetables . Relevant aspects of the Paediatric legislation should be considered as appropriate for each of the multiple applications submitted.
Find a specific business date and calculate the working days in a given period. Weekday Calculator – What day is this date? The Duration Calculator calculates the number of days, months and years between two dates.
Any clinical trial that is expected to continue after 30 January 2025 needs to be transitioned to CTIS. Please find below a collection of resources to assist sponsors throughout this process. • Guidance for the transition of clinical trials published by the European Commission under EudraLex
1 Ιαν 2024 · Find the number of years, months, weeks, and days between dates. Click "Settings" to define holidays. The Gregorian calendar is the most prevalently used calendar today. Within this calendar, a standard year consists of 365 days with a leap day being introduced to the month of February during a leap year.
