ii4sm will be at the DIA conference in Monaco, March 8th to 10th.
1. Join the sessions in Theme 2 / "Staying in Business: How to make sure you comply with all rules and regulations, quality, compliance and external challenges"In the EU, the Pharmaceutical Package and in other countries, other new rules and regulations have created new obligations. Also, advocacy groups, the public and the media – the scientific as well as the general press – are becoming more active and questioning. This makes the development of new medicines more and more demanding, not only from a clinical and scientific perspective but also from a process and regulatory aspect. Globalisation is, for instance, seen by some as progress as patients in developing countries are getting access to innovative medicines through earlier involvement in clinical trials and because of a strengthening of local economies through improved healthcare systems. Others are fearful that there is a shift in the focus of clinical development from industrialised countries to Asia and Latin America, thus depriving investigators in these “traditional” regions of access to clinical trials, and trials in developing countries are a new form of colonialism and result in the exploitation of vulnerable populations. The counter argument to this is a not uncommon topic in the debate about development: protection of patients in developing countries by well-intentioned and often self-nominated advocates from the so-called industrialised countries is nothing other than paternalism.Two sessions will look at this conflict and give background information about patients, the healthcare system and risks and benefits when conducting clinical trials in India and Latin America. In this context the expectations by the public for transparency do not come as a surprise and will be the topic of another session. Misuse of medicines and counterfeiting are other facets of globalisation and closely linked to the widespread use of the Internet. A session will review the so far rather neglected topic of misuse of therapeutic agents in doping. Doping would not be made so easy without manufacturing capacities in countries with weaker regulatory controls and e-commerce, and this leads to another session about counterfeiting. New regulations and mounting pressure are also an opportunity for smarter strategies and the use of “intel-ligence” for study management and quality oversight: progress of the Clinical Trial Transformation Initative (CTTI), innovative approaches to quality risk management that make extensive use of computerised processes and in the management of partners will be the focus of three sessions.
and meet with
Raffael Jovine, Vice President and Global Head of Business Development and Head for Stakeholder Engagement, ii4sm, Switzerland
for the session 0207 on March 10, 2010
NEW EFFORTS TO IMPROVE QUALITY AND EFFICIENCY IN CLINICAL DEVELOPMENT
Stakeholders in clinical development such as sponsors, investigators, CROs and health authorities have a common goal: protecting patients participating in a trial and ensuring the data collected allows for sound conclusions without bias from poor compliance. However, the approach to oversee clinical development activities and ensure compliance has been marked by a fragmented approach with little, if any, understanding on how economies of scale could be realised.
Amazingly other industries such as the aviation industry, in spite of fierce competition, have developed more sustainable models to drive quality and continuous improvement. There have been some attempts in the pharma industry to overcome the silo thinking but with no longer-term success. It is time to discuss new approaches and models in quality and compliance.
2. Join the sessions in Theme 9 / Risk Management
Risk Management remains a topic on everyone’s agenda. This year, we will reflect on the implementation of regulations by the European Medicines Agency and FDA over the last few years, describe some of the major research initiatives in the area and provide practical working examples from industry and regulators. Above all, the theme will reflect the multi-disciplinary approach that is required to create a clear picture of what we know, what we don’t know and how to address harm minimisation and benefit maximisation for patients and customers.
and meet with
Trevor Gibbs, Executive Vice President, ii4sm, Switzerland
for the session 0906 on March 10, 2010
PERFORMANCE, QUALITY CONTROL AND AUDIT IN PHARMACOVIGLANCE AND RISK MANAGEMENT
There is a complete range of flavours of signal management depending on whether you are:
- in a small or large organisation
- in a vaccine, consumer or pharma environment
- a data mining practitioner or not
Click here for the complete program of the conference.