Assuring data integrity; best practice

Transcription

1 Assuring data integrity; best practice Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA Thursday 16th March 2017 Data integrity is receiving much attention in the pharmaceutical industry, with several high profile cases where deficiencies have resulted in regulatory action, and the MHRA, FDA, EMA and WHO have all issued guidance documents recently. These guidance documents draw together the requirements of predicate rules and point the industry towards better practices in the life-cycle management of data records, from initial validation of data management systems, through daily operations, to long-term retention and archival practices. Although the scope is primarily support of GMP, the MHRA has recently drafted guidance for GLP, GDP and GCP, which applies the same standards across these related activities. This symposium will bring together experts from Health Authorities, pharmaceutical companies, CROs and technology -providers to discuss the approaches being taken to rise to the challenge of increased scrutiny of data management practices. Particular focus will be given to the changes that need to be implemented, and to the consequences for a GMP manufacturing organisation if it does not assure data integrity. Registration starts at 9.30 and the symposium starts at Speakers: Steven Brown - Novartis Dr Adrian Davis - Pfizer Worldwide R&D Dean Harris - Envigo Ltd Tracy Moore - MHRA Dr Gerhard Noelken - Data4Lab Ltd Paul Smith - Agilent Mark Stevens - Formpipe Life Science EXHIBITOR - BUTTERWORTH LABORATORIES Butterworth Laboratories Ltd are a UK based contract laboratory providing analytical chemistry services to the global pharmaceutical industry in support of R&D, Clinical Development and Licensed Manufacture. We are GLP, GCP and GMP compliant and FDA & MHRA inspected. We have extensive experience in the analysis of raw materials, finished products, devices and packaging in accordance with internationally published (EP, BP, USP, JP, JPE), client supplied or in-house developed methods.

2 A wide range of state-of-the-art analytical instrumentation compliment our classical competencies, enabling us to provide the most up-to-date and cost effective analytical services. Interested in this meeting? Please visit the JPAG website for full details at

3 Programme Introduction Dr Dave Elder, Chairman, JPAG Data Integrity: the regulatory perspective Tracy Moore, GMDP Operations Manager & Senior Inspector, Inspection Enforcement & Standards Division, MHRA Ensuring Data Integrity by design Dean Harris, Director Computer Systems Compliance, Envigo Refreshments Systems compliance: an instrument supplier s perspective Paul Smith, Global Strategic Compliance Program Manager, Agilent Technologies At the coal face: integrating data integrity requirements Steven Brown, Site DI Officer, Novartis Grimsby Ltd Lunch, exhibition and posters Phase-appropriate implementation of Data Integrity standards Dr Adrian Davis, Pfizer Worldwide R&D Data Integrity in the Cloud - So what's new? Mark Stevens, Formpipe Life Science Coffee Break Improve Data Integrity through better alignment between data gathering and laboratory work processes; working with a consortium of pharma and vendors to standardise data management Dr Gerhard Noelken, Data4Lab Panel discussion Close

4 Delegate information Registration fees Full fee 295 Fee for members of JPAG ** 195 Fee for bona fide student in full-time study 45 Fee for retired or unemployed members of JPAG 45 ** Details on how members of RPS and RSC can join JPAG are found on the JPAG website. Registration and payment of registration fees You can register on-line at Please SIGN IN to the site on your first visit before registering for an event; this will ensure that post-event delegate material is fully available to you personally. Full payment is required at the time of registration. Please pay ON-LINE by credit card (via Paypal). Notification that a registration has been accepted will be confirmed by to your registered e- mail address. If you have not received notification within five working days please contact JPAG at info@jpag.org. An invoice confirming your registration can be downloaded from the JPAG website. NO OTHER INVOICE WILL BE SUPPLIED. If payment has not been received prior to the event, then entry to the event will be at the discretion of JPAG. Payments may also be made by bank transfer. Cancellation policy Meeting registrations once made and accepted by JPAG are liable for payment and are not refundable. However, notified substitutions are permitted at any time prior to the meeting (see below). JPAG reserves the right to cancel a meeting due to circumstances beyond its control. In this case, JPAG will notify attendees by a message to their registered address at the earliest reasonable opportunity. It is the responsibility of registered delegates to monitor their and ensure their registered address is correct. In the event of cancellation, a full refund of payments will be provided. However JPAG will not be liable, to the extent permitted by law, for any consequential loss or damage arising from the meeting cancellation. Substitutions Substitute attendees from the same organisation are accepted at any time with no administration charge. Please notify JPAG in writing via to events@jpag.org with details of substitute attendees. Substitute attendees must possess an account or register a new account on the JPAG website in order for their registration to be processed. No refund is payable in relation to any substitution. The full meeting rate will be applied if the substitute attendee is not eligible for a discount and any additional payment is required before a registration can be accepted. Alterations to the programme JPAG reserves the right to alter the meeting programme, speakers, date or venue in the event of circumstances beyond its control. For the complete Terms and Conditions, please see the JPAG website. Other information Information on the programme, submission of abstracts for Poster presentation, location of the venue and local hotels, and JPAG membership is available on the JPAG website at: Other enquiries should be sent to events@jpag.org The contact details you provide on SIGN IN may be used to inform you about future JPAG, RPS and RSC events, products and services by post, phone or . However, you can elect not to receive information at any time by updating your profile on the website.

5 JPAG symposium programme Thursday 21st March 2019 Stability IV: Developments in stability testing and evaluation Royal Society of Chemistry, London Continuing our successful series of stability meetings, this is an essential event for anyone concerned with the management and assessment of drug stability: Hear from individuals involved in the regulation and inspection of stability and GDP Learn from industry experts on scientific developments in stability study design and interpretation Debate practical issues for evaluating data and predicting stability Examine ways to improve compliance and productivity in stability testing Network with other professionals and exhibitors Speakers: Dr Jonathan Bright - AstraZeneca John Cleverley - Clarivate Analytics Dr Paul Fullerton - AMRI Conor Jamieson - Sandwell and West Birmingham NHS Trust Dr Rachel Orr - GSK Dr Garry Scrivens - Pfizer Susan Smith - AstraZeneca Dr Maria Krisch - Freethink Technologies Inc Register now at Thursday 9th May 2019 Assuring the quality of medicines III; aseptic products Royal Society of Chemistry, London The quality of Aseptic products is the most critical challenge in the pharmaceutical industry. It covers those medicinal products that cannot be terminally sterilised, the majority of new injectable IMPs and all gene therapy and ATMPs. In addition, 2019 is a vitally important year as the revised Annex 1 becomes globally implemented and provides a host of challenges for the industry trying to implement it. JPAG has been able to bring together a unique and almost unparalleled group of speakers in a programme that tries to cover the hottest topics in this field. There will be adequate time after each presentation to discuss case studies and practical implications. Register now at Thursday 11th July 2019 Analytical challenges of new modalities

6 Royal Society of Chemistry, London The purpose of this symposium is to Identify areas for harmonisation of oligonucleotide development and propose solutions to influence the external regulatory environment; expediting patient access to revolutionary medicines Register now at Interested in any of these meetings? Please visit the JPAG website for full details at