Whilst drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common challenges.
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
Latest insights and innovations in PV impacting the technology space
The PV Context and Driver
- Relentless regulatory changes, with more on the horizon, e.g. ICH E2B R(3), IDMP, EU Clinical Trial Regulation, Eudravigilance, Medical Device Regulation
- Shifting global boundaries, stagnating established markets, new models for emergent markets
- Dramatic changes in the Pharma landscape will shape future PV models and processes>
The PV Challenges faced by member companies
- Increased scrutiny by health authorities on regulatory changes and imminent deadlines for system implementation
- Expanding remit of boundaries spanning outside of PV
- Remaining compliant, driving efficiency and value with less resources
- System availability from vendors meeting regulatory requirements (E2B R3 and IDMP) impacting technology buy/build decisions
- Keeping systems validated and inspection ready
- Gearing for future requirements
Recent PV Solutions debated by members
- Latest regulatory insights: social media, data privacy, increasing enforcement, and the rise of quality
- Working across boundaries - setting structured responsibilities and governance across the PV system
- Comparative data analysis for driving lean operations, KPIs for now and the future
- E2B R3 and IDMP readiness
PV Opportunities for further debate and predictions
- Managing the data explosion from digital media: new, public, and unstructured sources
- Leveraging technology to enable predictive analysis and safety…real-time Benefit-Risk?
- Striking the balance of seamless integration: global consistency and local difference
- Driving innovation with new capabilities to explore new PV systems and models for the futur
Why join pvtech?
- Industry networking opportunities
- Builds profile of company and PV function
- Encourages sharing of ideas and strategic thinking
- Provides quantitative and qualitative performance benchmarks
- Access to the latest PV insights through webcasts, think tanks, community exchange
- Brings to life good practices
- Defines and prioritises improvement initiatives
- Independent validation and facilitation