Regulatory Affairs Network

CEE & CIS CT Forum

Wednesday, 25 January 2012 00:00 Fleming Europe Events - Events

5th annual CEE & CIS CT Forum

18-19^th April 2012, Vienna

The increasing demand for eligible study patient populations in order to prepare markets for new medicines as well as the need for more cost-efficient clinical development programs are the key reasons why the pharma industry is conducting clinical trials in the CEE and CIS region. However, there are a number of challenges that all industry stakeholders need to overcome in order to conduct clinically and commercially successful trials.

Quality and Process Excellence

Tuesday, 17 January 2012 17:00 Kakushin Group Events - Events

Applying Quality and Process Excellence in Pharma

18 April 2012

Pharma Industry failes to keep up with other industries in terms of manufacturing efficiency and productivity, largely because of the cost and limitations involved in revalidating any process changed in the spirit of improvement. Once manufacturers confirm or validate their processes as compliant, they traditionally have been very reluctant to change them and introduce the innovation in the manufacturing processes. The simple fact is that pharmaceutical manufacturers, which historically have enjoyed consistently robust profit margins, have had little economic incentive to introduce change.
Applying Quality and Process Excellence in Pharma is a 1/2 day web-forum focused on Quality and Process Excellence.

Audit and Regulatory Inspection

Wednesday, 16 November 2011 09:26 EICCRP Events - Events

PREPARING FOR AUDIT AND REGULATORY INSPECTIONS

Ensuring the Success of your Clinical Trials

Vienna, 16^th - 17^th February 2012.

Do audits and inspections affect your work? What do you do when the EMA or the FDA comes knocking? Are you absolutely confident that everyone is fully prepared? Every clinical trial is subject to audits as well as health authority inspections from time to time, verifying compliance with rigorous requirements that have in fact changed significantly over the last few years. In this MasterClass you will learn, develop and practice what you need, to be ready when the call comes, taking you through from the announcement to the end of the process.

We are cordially inviting you to join us for our next advanced MasterClass titled Preparing for Audit and Regulatory Inspection in Vienna on 16^th - 17^th February 2012. The event has been designed to allow plenty of opportunities for discussion and sharing best practice.

Attending you will:

• Understand how to prepare for EMA and FDA audits

• Learn how to plan for an audit or inspection including the use of appropriate checklists/EMEA inspection guidelines

• Know how to prepare for audit/inspection interviews

• Acquire a greater understanding of responding to the audit/inspection findings

•Improve your ability to carry out corrective and preventative action in response to inspection findings

About the course leader:

Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has almost 20 years of experience in running clinical trials and clinical quality assurance in the pharmaceutical industry.

Join us and SAVE

Early Bird Discount until December 16^th

Incremental group discounts start from 2 persons!

For more information, detailed agenda and group discounts please contact us at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it or visit our site at www.eiccrp.eu.