Top Agenda topics for 2019:
30 January 2019– Pre-conference sessions in conjunction with the Pharmacovigilance Conference (0ptional)
Pharmacovigilance- Regulatory interplay:
- How safety signals are monitored and followed-up in regulatory, quality and other areas of medicines life-cycle?
- Living in the digital era: are we using its potential?
31 January- 1 February 2019- Regulatory and Scientific Affairs Conference
- Tackling the effects of the globalisation of pharmaceutical operations – challenges, opportunities and priorities
- Watch this space in 2019!
- > Countdown to Brexit – the latest update on the withdrawal agreement and regulatory consequences
- > Implementation of the Medical Device Regulation- how is it going to affect combination products?
- > New ICH guidelines under development: what is new and what impact can be expected?
- > Recent developments in the EU telematics environment
- Global development for generics/ complex generics- can a dream come true?
- Evolution of the Environmental Risk Assessment for Medicines- what should the regulatory experts know about future changes?
- Electronic product information – what is the best model and standard for the future? – update on the continuing discussions
SPECIAL SESSION: Put your questions to the Regulators. An opportunity to address questions to the European Regulators
To secure your place at this ‘must attend’ platform, please register now and you too can share information with leading experts and network with your peers.
Follow the event on Twitter – #RAC2019