Changes to pharmaceutical legislation are fast approaching. What can you expect over the coming years? The debate during the conference will give you a better understanding of the direction of changes and how to make your company ready to implement them.
- Preparing ground for European competitiveness, economic viability and growth. Medicines for Europe Strategic Vision 2030 – how to strengthen Europe’s competitiveness for resilient off-patent medicines supply, development, authorisation and manufacturing; how to secure the economic viability of the off-patent medicines business model; and unlock future growth.
- Dealing with early applicability of new availability provisions and their immediate impact on companies’ regulatory and supply chain operations
- Managing the implementation of the revised pharmaceutical legislation – how to understand transitional provisions and their applicability to legacy products
- Exploring new opportunities for development of off-patent medicines arising from the new legislation and from public health and patients’ needs
- Managing future Marketing Authorisation submissions in view of up-coming changes to dossier structure (implementation of ICH M4Q, eCTD 4.0, revised Annex II, digitalisation of variations reporting, moving towards data driven submission)
- Managing future Marketing Authorisation submissions and procedures in view of on-going implementation of the new EU legislation: shortening of CP and DCP timeline to 180 days, pre-submission interaction with the Authorities, opting-in in the DCP, withdrawal of immature dossiers
- Embracing upcoming changes in EU legislation affecting labelling and electronic product information – the readiness of technical solutions and the steps necessary for their practical implementation in the short, medium and long term.
Three webinars:
- Webinar 1 – Risk Management Plan (RMP) for off-patent medicines in view of the revised Pharmaceutical Legislation
- Webinar 2 – Embracing digital transformation – key steps for Industry to take in the short, medium and long term
- Webinar 3 – How to comply with new environmental obligations? (TBC)
