
The R&D sector within Life Sciences Industries is facing numerous challenges:
The emergence of new information technologies (removal of paper-based document processes, XML, hyperlinks, e-rooms, content management, collaborative work, portals, intranets/extranets, electronic signatures, e-CRFs, "in silico" trials, linguistic tools for data searches, automatic indexing of scanned documents, etc.)
Rapid changes in regulations and guidelines in the regulatory field (procedures for submitting to the EU, (e)-CTDs, eModule 1, application forms, CTAs, eINDs, structured labelling, structured study reports, etc.)
The increase in the burden of proof, and in the requirements for data traceability throughout the value chain as well as in the number of areas covered by best practice (for human trials and in accordance with pathologies/populations, for "in vivo" trials, "in vitro" trials, manufacturing, packaging, environmental considerations, etc.)
The growing complexity of the internal and external network of partners/companies involved in the research and development of products, notwithstanding the complexity of emerging scientific technologies.
The ever-increasing challenges associated with innovation (and the protection of such innovation) in a very competitive and politically sensitive market.
All of these elements are interconnected. In particular, they "challenge" the information systems that support and organise the numerous activities involved in identifying, commercialising and developing the products supplied to the various stakeholders in the Health industry: the product lifecycle. In 2002, we therefore made the decision to provide the Industrial community of the Life Sciences industry with a neutral forum that would facilitate informal discussions relating to the multiple facets associated with product lifecycles and the role of information systems in these areas.
Each business breakfast has a specific theme, illustrated by one or more presentations. Discussions are chaired by Product Life and a summary report is provided. Today, this informal network comprises more than thirty companies from the sector, of varying size, with an average of at least fifteen of their representatives attending each business breakfast.
Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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Friday 20.01.2012
Petit-déjeuner à Paris: La gestion globale de l'information des produits pharmaceutiques
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