ACDM Webinar - Recent Developments in GCP & Regulations From a Data Management Perspective



Start date
05-Jul-17


End date
05-Jul-17


Location
Webinar


Contact Details




Event Details

Course overview
This webinar provides an insight into how current regulations and guidelines need to be applied in the data management arena in order to ensure effective compliance with relevant laws.

Who should attend?
This webinar will provide you with an insight into how current regulations and guidelines need to be applied in the data management arena in order to ensure effective compliance with relevant laws. 

The training course is updated annually so that you can be sure you have the most up to date information.

This webinar is for anyone working in data management on clinical trials.  Why not gather a group together to ensure your team is up to date!

Content
• History behind the development of the regulations for trials involving human subjects
• Application of:
- ICH GCP
- Good Clinical Guidelines (E6)
- Directive 2001/20/EC
• Implementation of GCP in the conduct of clinical trials on Medicinal Products for Human Use
• Directive 2005/28/EC
• UK Statutory Instrument
• The Medicines for Human Use (Clinical Trials) Regulations 2004, and its amendment dated 2006
• Directive 95/46/EC
• Processing personal data and how to address privacy requirements
• The Data Protection Act 1998
- 2001/20/EC Article 3, 2(c)
- What is personal data and how to address privacy requirements as a Data Manager
• How to prepare for an MHRA/FDA inspection
• HIPPA (privacy in US)
• 21CFR part 11
• Safety Reporting
• Protocol Deviations

By the end of this course you will:
• Understand why regulations have developed as a reaction to historical events
• Have gained an overview of all the regulations relevant to clinical trials
• Know how relevant regulations need to be applied when managing clinical data
• Know how to operate within the law when processing personal data

Webinar Details:
Date: 5 July 2017
Time: 12:00 – 13:30 GMT
Duration: 90 minutes
Venue: Webex
Instructor: Jon Wood

Instructor Profile
Jon Wood has a degree in physiology and brings nearly 25 years of industry experience across project management, biometrics and strategic sourcing roles within blue chip pharma and Contract Research Organisations.

MEMBERS ONLY DISCOUNTS Available:
Multiple Course Discount - If you book another course within 24hours, you will receive 20% off each course
Academia / Public Sector Discount - You will receive 15% off this course
Discounted rates are also available for contractors / freelancers - email admin@acdm.org.uk for more information

How to Claim the discount: When booking, select Invoice (instead of credit card) and also email admin@acdm.org.uk to confirm your name, course you have booked on and the discount you are entitled to. The discounts will then be applied and shown on your invoice.



Group Size 1-15 people

Webinar participation is £150.00 + VAT for members and £250.00 + VAT for non members. This price is for one location with 1-15 people participating. All delegates must be in the same room and be sharing one telephone line to dial in. Proceeding to book a place on this course you are agreeing to our terms and conditions.(Please note: you need to log in as a member for the members rates to show below when booking)

Click here to view the terms and conditions.

Price: £250.00



Group Size 16 - 50 people

Webinar participation is £200.00 + VAT for members and £300.00+ VAT for non members. This price is for one location with 16 - 50 people participating. All delegates must be in the same room and be sharing one telephone line to dial in. Proceeding to book a place on this course you are agreeing to our terms and conditions. (Please note: you need to log in as a member for the members rates to show below when booking)

Click here to view the terms and conditions.

Price: £300.00









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