Our annual conference again offers you ideal opportunity to learn about our solutions and new features, to listen to experiences from our customers and partners, to get insight into current events and future trends in pharmaceutical industry.

The conference takes place on the 25th – 27th May 2011 and offers free pre-conference workshops, including the following.

Friendly software solutions for the pharma industry (workshops for potential costumers – 25th May):

• How to Achieve Efficient Drug Registration Process with help of document management system ?
• Case study – INFOTEHNA’s solution for regulatory affairs in G.L. Pharma
• Managing QA / QC documentation with One Solution – from Quality Policies and guidelines, SOP’s and training to change control, CAPA, deviations and much more
• Case study – INFOTEHNA’s solution for quality assurance in Belupo
• Impossible made easy: handling the documentation requirements in R&D – planning, formulation and pilot development, batch records, process validation, labeling, stability testing and more
• All-in-one solution for Pharmacovigilance – system documentation, reporting, safety update reports and knowledge base

Sharing our knowledge (workshops for existing users – 25th May):

• Tricks of submission management
• Demonstration of training management tool
• Pharmacovigilance documentation in an electronic system, including
• Communication with regulatory authorities
• Questions, suggestions, opinions and debate

Regulatory affaits and pharmacovigilance (Stream 1 – 26th May)

• Field report – regulatory situation in CIS and Middle East
• What happens with eCTD after submission?
• US submission management – PADDOCK case study
• Integral document management for agencies – ALIMS case study
• New EU pharmacovigilance package – what did we get?
• EDMS integrated pharmacovigilance system – BELUPO case study

Quality and development (Stream 2 – 26th May)

• Risk management as quality system foundation – build on solid ground
• How does integral EDMS based QA / QC solution work? – SOPHARMA case study
• Training management in pharmaceutical company
• Project organization in pharmaceutical development and required documentation
• Tips and tricks from GRINDEKS: Access EDMS information via Excel reporting tool
• Learn from FARMACHEM Experience: selection of API suppliers for new projects

User group meeting (May 27)

– What’s new?
– User group meeting

All days: Hands-on Corner

• Work with the trial system: test functionalities, consult our experts, and get answers to your questions

For more information about the event please click here.

To register online please click here.