Conferences

Adaptive Trials 2008 
9 - 10 September 2008, Barcelona, Spain

VIBpharma’s Adaptive Trials 2008 conference will provide thorough insight into the very latest challenges and initiatives concerning adaptive trials. The conference will cover a multitude of key issues from the regulator’s discussing their future aspirations through to experts from pharma manufacturers and biotechs sharing teachings from their never before discussed European trials.

Further information is available here.

Contract Good Manufacturing Practice (GMP) Quality Control (QC) Labs Symposium
10 September 2008, MHRA Market Towers Offices, London

This event provides both licence holders and the QC laboratory with an opportunity to meet the Medicines and Healthcare Products Regulatory Agency (MHRA) inspectors and gain a greater insight into the current inspection programme.

Presentations will be given which outline the key issues with quality systems, highlight the common deficiencies and describe the MHRA expectations. Guidance will be given on method validation and microbiology testing issues and expectations.

This event will be of interest to all people working for independent QC testing laboratories contracted to conduct release testing of medicinal products, intermediates or active pharmaceutical ingredients and all individuals within the Pharmaceutical Industry responsible for contracting out tests related to medicinal products (including intermediates and active pharmaceutical ingredients) and their subsequent assessment as fit for purpose.

For details are available here.

Paediatric Drug Development and Clinical Trials
30 September - 1 October 2008, Brussels, Belgium

Paediatric drug development is a highly complex area for drug manufacturers and one which is now obligatory to consider. Before any medicine is authorised for use in adults it must have undergone stringent testing to ensure it is safe an effective. However, this is not the case for medicines for children. In the EU over 50% of medicines used in children have only been studied in adults and the use of off-label prescribing for children can have serious effects.

With the introduction of the medicines in children regulation last year it is now obligatory for all drugs to have trialled and tested paediatric indications, meaning that manufacturers are facing many new challenges. From an update of the legislative framework and case studies of trials in progress to patient recruitment, informed consent and the ethics of paediatric trials, this event will cover the major issues that drug developers are facing today.

Further information is available here.

Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP) Symposium
11 & 12 November 2008, Crowne Plaza, Liverpool

The Medicines and Healthcare Products Regulatory Agency (MHRA) has announced two days of events aimed at Qualified Persons (QP), Responsible Persons (RP) and all individuals involved in GMP and GDP Inspections. Delegates can choose to attend Day 1, Day 2 or both days according to their roles.

Day 1 – Good Manufacturing Practice – Best Practice for QPs
The first day will highlight the role and requirements of the QP, providing guidance on inspections and common deficiencies within both a domestic and international supply chain. The event will also enable delegates to meet and pose questions to the GMP Inspectorate.

Day 2 – Good Distribution Practice – Best Practice for RPs
Day 2 will focus on the role and requirements of the RP, inform delegates on how to prepare for and participate in an MHRA inspection, learn from common system failings through interactive workshops based around frequently raised deficiencies and understand how the Agencies Risk Based Inspection programme will impact upon the role. The event will also enable delegates to meet and pose questions to the GDP Inspectorate.

Further information is available here