Webinar 1 – ACCESS, AVAILABILITY AND SHORTAGES ARE CENTRAL TO PHARMA STRATEGY: HOW WILL REGULATORY REFORMS DELIVER?
24 JANUARY 2022 – 14.30-16.00 CET
The opening session will focus on the European Commission’s Pharmaceutical Strategy and how legislative and regulatory amendments can deliver better access and supply of medicines.
Webinar 2 – The future of generic competition and how to leverage global convergence
26 JANUARY 2022 – 14.30-16.30 CET
In this session we will discuss global convergence efforts for generic medicines, looking at the current legal framework and the way forward. We will explore the opportunities provided by parallel EMA/FDA Scientific Advice and how new approaches to bioequivalence can open the door to a new era in generic development, access and availability.
Webinar 3 – Upgrading Marketing Authorisation procedures to increase availability and tackle shortages and supply chain resilience
31 JANUARY 2022 – 14.30-16.30 CET
The session will focus on necessary changes to MA procedures: modernise the DCP/ RUP; changes to CP, self-standing ASMF assessment, variations to support the Pharma Strategy objective to optimise the regulatory processes and deliver on faster patient access to medicines.
Webinar 4 – Delivering on global patient safety in pharmacovigilance
2 FEBRUARY 2022 – 14.30-16.30 CET
We will discuss the developments in pharmacovigilance and understand how a global view of patient safety can impact day to day practice and implementation.
Webinar 5 – Mobilising the digital opportunity to achieve interoperability in the EU medicines agency network
3 FEBRUARY 2022 – 14.30-16.00 CET
This session will look at advancing digitalisation to achieve interoperability and successful digital transformation for a truly integrated regulatory system.
Webinar 6 – Prioritising regulatory reforms to increase access to medicines and to mitigate shortages
9 FEBRUARY 2022 – 14.30-16.30 CET
This session will recap the key solutions and benefits for access and supply discussed in the conference and look at how to prioritise the reform agenda in line with the ambitious vision of the Pharma Strategy. One objective will be to align regulatory and industry timelines to deliver as quickly and efficiently as possible.