Clinical Trial Regulation Workshop
In-Person Event
Dec 06 - 07, 2016
London, England, GBSpeakers
OVERVIEW
This 2-day workshop on Clinical Trial Regulation will provide a forum for information exchange and discussion on conceptual and practical questions through lectures and panel discussions.
While publication of the Clinical Trial Database is delayed, the endorsement of the Clinical Trial Regulation is moving forward in other areas. The Clinical Trials Forum will focus on the differences between, the present and new requirements on managing clinical trials in the face of forthcoming changes.
This 2-day workshop will provide a forum for information exchange on both conceptual and practical questions of:
- How will the new legislation change the processes and the format of the trial application?
- What are the impacts on how a clinical trial is managed after approval has been granted?
- What are the critical issues affecting sponsors and Member States as they consider changes needed to implement the regulation?
- How will the new provisions for public access to an EU Clinical Trials Database enforce disclosure of clinical trial data and information?
Attendees will participate in the collaborative discussions through lectures, panel discussions and interactive sessions.
Learning objectives :
- Understand the new requirements along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
- Identify the key challenges and opportunities of the new requirements and policies
- Leverage insights on how companies and research institutions are fine-tuning and optimising
- processes to meet the requirements of the Clinical Trials Regulation
- Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders
The course is suitable for people working in the pharmaceutical industry and contract research organisations, from clinical science and clinical operations Monitors, auditors of clinical trials, Regulatory affairs personnel, and Pharmacovigilance staff.
Price :
Early Bird: EUR 1230
Standard: EUR 1585
Members: EUR 1430.
While publication of the Clinical Trial Database is delayed, the endorsement of the Clinical Trial Regulation is moving forward in other areas. The Clinical Trials Forum will focus on the differences between, the present and new requirements on managing clinical trials in the face of forthcoming changes.
This 2-day workshop will provide a forum for information exchange on both conceptual and practical questions of:
- How will the new legislation change the processes and the format of the trial application?
- What are the impacts on how a clinical trial is managed after approval has been granted?
- What are the critical issues affecting sponsors and Member States as they consider changes needed to implement the regulation?
- How will the new provisions for public access to an EU Clinical Trials Database enforce disclosure of clinical trial data and information?
Attendees will participate in the collaborative discussions through lectures, panel discussions and interactive sessions.
Learning objectives :
- Understand the new requirements along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
- Identify the key challenges and opportunities of the new requirements and policies
- Leverage insights on how companies and research institutions are fine-tuning and optimising
- processes to meet the requirements of the Clinical Trials Regulation
- Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders
The course is suitable for people working in the pharmaceutical industry and contract research organisations, from clinical science and clinical operations Monitors, auditors of clinical trials, Regulatory affairs personnel, and Pharmacovigilance staff.
Price :
Early Bird: EUR 1230
Standard: EUR 1585
Members: EUR 1430.
KEY DATES
06 Dec, 2016
Event Start Date
07 Dec, 2016
Event End Date
SPECIALITIES
Pharmacy and MedicineSUGGESTED HOTELS
CONFERENCE VENUE
Amba Hotel Marble ArchRELATED CONFERENCES & LIVE WEBINARS
Quick Links