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CRED Regulatory Operations Including ECTD
This course will take you through the key functions of a regulatory operations department and how its effectiveness can be maximised.
When:
13 - 14 December 2017
Where:
TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom
What is it?
Regulatory Operations is a key part of any pharmaceutical company, and this workshop will provide an awareness of the operational aspects of preparing and submitting a regulatory dossier to seek health authority approval, as well as taking you through how regulatory operations fits in with the other key departments involved in this process. Delegates will be given detailed overviews and presentations that will highlight strategies to maximise on resources, tools and on cost for companies of all sizes.
Who is it for?
This course is for those who would like to learn more about regulatory operations and eCTD.
What will I learn?
Click here to view a copy of the programme, which includes each sessions learning objectives.
This course will cover:
Structuring an Operations Group
Planning for success
Regional and global support strategies
Resource management
Outsourcing/ Internal teams
Communication and virtual teams
The impact of guidance and legislation
Technical and format required (eCTD/ Validator and DMS tools)
Cross industry collaborations
Case studies on how strategies, processes and resources differ from large pharmaceutical companies to a small organisation
Management of regional administrative documentation and requirements necessary to submit to ROW markets
Global requirements
Reuse of dossiers across regions
Local representative requirements and impact on delivery
Life-cycling: Best practice
CPD:
12
How do I apply?
Simply
login
or
create an account
and register below.
Course fees:
Type
Member
Non-member
Standard
£925+VAT
£1,095+VAT
Discounted places
A limited number of discounted places are available at the rates below.
Please email us for a discount code
before
making your booking.
Those working for regulatory agencies, government agencies or academic institutions
£693.75+VAT
£821.25+VAT
Those working for charities, patient groups or are in full-time education
£462.50+VAT
£547.50+VAT
Terms and conditions
Please read the
training terms and conditions
before booking this course. By booking a place on this course you are agreeing to the
training terms and conditions
.
When
13/12/2017 - 14/12/2017
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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or
create an account
to register
My registration status:
Not registered
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking -
If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email
finance@topra.org
Register now
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