Workshop on evaluating RWE from observational studies in regulatory decision-making

12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...

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First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development

18 March 2020 - Today, the first global regulatory workshop on COVID-19, was convened under the umbrella of the International Coalition ...

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‘Regulatory science to 2025’: live broadcast of post-consultation workshop

11 November 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its ...

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Developing real-world data and evidence to support regulatory decision-making

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...

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Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application

20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how ...

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Shaping regulatory science to 2025

17 October 2018 - EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the ...

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FDA and EMA to hold workshop on breakthrough therapy and PRIME designations

2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...

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Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience

7 June 2018 - Agenda and list of speakers for 13 June hearing available ...

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Working together for people with rare and complex diseases

22 May 2018 - Live broadcast of workshop with European Reference Networks on 29 May. ...

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Workshop on paediatric regulation – stakeholders to discuss how to boost development of medicines for children

19 March 2018 - Event to be broadcast live on 20 March. ...

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How to better apply the paediatric legislation to boost development of medicines for children

31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...

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How the EU regulates medicines

11 September 2017 - Awareness session for international regulators and NGOs on the work of EMA and European medicines regulatory ...

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FDA sets inaugural meeting of first-ever patient engagement advisory committee

25 July 2017 - Imagine checking your blood sugar levels several times a day with a glucose meter to keep your ...

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PDA/FDA Biosimilars Conference - 26-27 June 2017

3 May 2017 - The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval ...

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Personalised medicines – focus on patients and healthcare professionals

7 March 2017 - EMA workshop will discuss role of patients, consumers and health care professionals. ...

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