Understanding the regulatory direction and how to meet it – The path through RBM to Quality by Design
November 12, 2019
OVERVIEWThe FDA and EMA guidance documents (2013) that led to the initiation of RBM in clinical trials, have been cemented with the ICH E6 R2 (GCP) update in 2016. There is much more in the ICH GCP update, and this items together with RBM take us on the regulatory desired path of Quality by Desig (ICH E8 – draft May 2019).
The methods of Josef Juran (“Father of Quality by Design”) will be examined as well as application to clinical development.
Finally, the presentation will cover want tasks in Clinical Data Management are essential to QbD.
WHAT YOU'LL LEARN
- Understand the Regulatory Direction to Quality by Design
- Quality by Design methods and application to clinical and product development
- Identify key CDM tasks that are part of Quality by Design
- Define how CDM tasks can become part of Quality by Design
WHO SHOULD ATTENDIntended level: Intermediate to advanced
WHAT ARE THE BENEFITSUnderstand the application of QbD principles to turn tasks into QbD opportunities.
MEET THE PRESENTER
William Andrew Lawton, Consultant Director, Risk Based Aproach LtdAndy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials.
He is currently consultant and director of Risk Based Approach Ltd and has worked with a variety of companies and institutions on the implementation of ICH E6 R2 and Risk Based Monitoring.
Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim, were he also held positions of increasing responsibility during his 32 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency.
His most notable publication is the paper with Dr. Alistair Ross on GP Audit - throughout 80's and 90's this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.
EARN CEUsParticipants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
|Group (max. 10 ppl.)||$960||$1,140|
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.
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