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2nd March 2018
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London, UK
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100 Seats
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10 Speakers

Why Should You Attend?

Data Integrity has become the “buzz” word in the pharmaceutical industry. Each regulatory application or approved product carries a commitment from the company to the regulatory authority to manufacturer only the finest quality products. Observations from all major regulatory authorities to companies around the globe indicate that many may not be taking their commitment seriously.

Hear former EMA Head of GMP Compliance, David Cockburn, Ph.D., current MHRA Data Integrity expert Stephen Grayson and Gary Bird Ph.D. (former FDA) discuss the current focus on Data Integrity within the regulatory authorities. Eight industry speakers will discuss their efforts to manage the ever-increasing volume of information within the company using the current tools at its disposal; while keeping in mind the real costs incurred due to over-zealous pursuit of data integrity perfection.

Conference on Data Integrity in Pharmaceuticals

Friday 2nd March 2018 in London (UK)

Key Note speakers include Stephen Grayson (MHRA), David Cockburn (formerly EMA), and Gary Bird (formerly FDA) and speakers from MSD, Novartis and GSK. This international conference will be chaired by Professor Gino Martini.

The First International Conference on Data Integrity in Pharmaceuticals will be held at the PriceWaterhouseCoopers conference centre at 1 Embankment Place London WC2n 6RH Telephone +44(0)20 7583 500. Download Conference Venue

Book Now

- Your Early Bird Conference reservation before 5th February 2018 ; £700 Inc VAT/deligate
- Delegate rate after 5th February will be £795 Inc VAT/delegate


"For B2B invoice email John.jolley@pharmaconsultglobal.com giving name of delegate to be registered for Data Integrity conference"

Your early Bird Conference Hotel reservation before 1st February
- £205.00 room per night single occupancy Inc. VAT & breakfast
- £215.00 room per night double occupancy Inc. VAT & breakfast
Quote your Group reference PHAR010317;
https://www.amba-hotel.com/en/london/charing-cross/contact.html

£795.00 Pay Now

For B2B invoice, Contact John Dr Jolley

Conference Program

Morning Session
7:30 - 12:30
Afternoon Session
14:00 - 18:00
Finding the venue
 
TimeSubjectSpeakers
The Regulatory Environment
7:30 – 8:30 Registration and continental breakfast  
8:30 - 8:40 Welcome  
8:40 – 9:10 The EMA/FDA Mutual Recognition Agreement and Data Integrity
9:10 – 9:50 Behavioral Elements of Personnel That Can Lead to Data Integrity Issues with a summary of data integrity observations in inspections
9:50 -10:10 Q&A Session  
10:10 - 10:30 Break  
10:30 - 11:00 Ensuring Data Integrity: The MSD Approach
11:00 – 11:30 Annex 16:  The critical role of the QP in preventing and resolving data integrity issues of:
  • GMP compliance of API and Excipients.
  • Qualification of materials in Supply chain
John Dr Jolley

John D. R. Jolley ex Boehringer Ingelheim

11:30 - 12:00 The Impact of GAMP V on Data Integrity Discussions
12:00 – 12:30 Q&A plus open discussion with morning speakers  
12:00 – 12:30 Lunch