April, 3-5, – the Crowne Plaza Barcelona, Barcelona, Spain
Ennov, a Regulatory and Quality software vendor, exhibits its Regulatory Software Suite and Quality Management Software at the ISPE 2017 Europe Annual Conference at the Crowne Plaza Hotel (Booth 13), set to begin April 3rd.
At the ISPE Annual Conference, we will be sharing our IDMP Whitepaper and present our eCTD247 solution which enables you to publish PSUR in eCTD format, as mandated by the EMA since June 2016. eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time. We will also be showing our RIM solution to meet your RA deadlines.
eCTD247 is the only online eCTD solution that
- Has a pricing based on the number of documents in your submissions
- Is very easy to use, with minimal training time to become efficient and start publishing and submitting your eCTD
As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.
At the same time Ennov is sharing its integrated QMS software (cloud or on premise solution) which helps reduce quality management costs, achieve risk-based quality management, comply with GMP requirements at the ISPE conference.
Today’s industrial world is changing with digitization. The impact on the pharmaceutical world is increasingly felt. Change is taking place consistently, in all areas: more open production systems, more vulnerable to external attacks. The conference will address three focal points :
- Results from the work of GAMP working groups: Revised GAMP Good Practice Guidelines: verification of machine interfaces (M2M), amendment of the guideline for verification of the IT infrastructure, supplier audits
- Production systems operation: treatment of deviation / Change Control, Audit Trail Review and decommissioning of systems
- System and data security
ISPE’s Europe Annual Conference is a conference for leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.
This serves as the premier place for the discussion of processes, globalization, scalability, regulation and quality best practices including innovation and technology.
This years “Pharma Manufacturing 2025″s theme highlights how production, manufacturing, and the industry may change. Additionally, prominent questions will be explored and discussed such as what the main regulatory trends might be by 2025 and how will current technology platforms will evolve.