CRED Project Management for Regulatory Affairs Professionals

CRED Project Management for Regulatory Affairs Professionals
A two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.

Where:TOPRA, 6th Floor, 3 Harbour Exchange Square, South Quay, London, E14 9GE
When: 2-3 August 2018 
Start time (Day 1):  09:15
End time (Day 2):  16:30


What is it?
A two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals. This course aims to provide an understanding of how to scope and deliver complex regulatory projects to tight timelines, effectively manage documentation, assess and manage risk and work effectively with teams and stakeholders.

Who is it for?
This course is for:
  • Regulatory staff at establishing to driving level working in any aspect of regulatory affairs where they are involved in delivering or managing projects
  • For more senior staff where they are running more complex projects or managing a range of projects and want to make sure they have up to date skills and gain from shared expertise
  • Project Managers with responsibility for regulatory projects who want to understand regulatory aspects

What will I learn?
This course will cover:
  • What project management is and how it fits with Regulatory Affairs
  • Planning phases for regulatory projects
  • Effective management of documentation
  • Effective project teamwork and managing stakeholders
  • Managing timelines and budgets in a regulatory environment
  • Risk assessment and management
  • Timelines, Milestones and techniques to keep everything on target
Download the course preliminary programme

CPD: 12 

Presenters 
Joe Cheal
Joe Cheal, from Imaginarium Learning and Development, has been training, consulting and coaching since 1993, working with thousands of people from a diverse range of companies over the past 25 years. He is a highly interactive and engaging speaker who focuses on practical solutions for ‘real world’ implementation.



Dipesh Mistry
Dipesh Mistry started his regulatory journey after a brief encounter in Pharmacokinetics and has worked in departments such as CMC, Submission Management, Project Management and, more recently, the Oncology space within Pfizer’s Established Health business. He has worked in a variety of organisations, including big pharma, generics, CROs and consultancies. He is a big supporter of science education and volunteers as a STEM ambassador for London and the south-east of England.


Sinead UsherSinéad Usher
Sinéad Usher has over 20 years of regulatory experience. She is currently the director of SMART Regulatory Services, a provider of regulatory expertise to large Pharma and CROs. Assignments have included Regulatory Project Manager roles with responsibility for portfolios such s vaccine (biological), anaesthetics, critical care and HIV. Other regulatory assignments have included Labelling Audit Project, Regulatory Intelligence, Common Technical Document conversions and auditing dossiers for submission. Sinéad is a registered pharmacist and has a postgraduate diploma in regulatory affairs with distinction.
 

TOPRA Summer School Offer 
Book this course with the CRED Practical Document Writing and Management course and receive two Global Development webinars worth up to £200!

Click here for more information and to book this offer. 

How do I apply? 
Simply log in 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 at meetings@topra.org 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
02/08/2018 - 03/08/2018
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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