News

A new corporate website for the European Medicines Agency

A new version of the European Medicines Agency (EMA) corporate website has been launched in September 2018, providing a number of new features to improve user experience, including: an improved search, allowing users to find content easily and to filter their search results. EMA plans to further refine this functionality in the future; a ‘responsive’

October 11th, 2018|

SAVE THE DATE – 29 September 2018, Erlangen. Paediatric Clinical Pharmacology 2018 – Basic and Clinical Implementation

A scientific farewell symposium for Prof. Dr. Wolfgang Rascher, director of the Department of Paediatrics and Adolescent Medicine Erlangen will take place on 29 September 2018 at the Universitatsklinikum Erlangen (Germany). National and international speakers from the field of paediatric clinical pharmacology will participate to the symposium. The deadline for the registration and the abstract

August 28th, 2018|

SAVE THE DATE. 11 September 2018, London. Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories

The European Paediatric Formulation Initiative (EuPFI) will hold a workshop on 11th September 2018 at the University College London (UCL) School of Pharmacy on the theme “Improving the administration of paediatric oral liquid medicines using dosing syringes and enteral accessories”. The meeting intends to promote the discussion on the current challenges and the potential improvements

August 28th, 2018|

SAVE THE DATE. 5-6 September 2018. Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients

On 5-6 September 2018 the third multi-stakeholder Paediatric Strategy Forum, jointly organised by ACCELERATE and the European Medicines Agency (EMA) will take place in London. The meeting will focus on checkpoint inhibitors used in combination therapy in children and adolescents. Immune checkpoint inhibitors have shown impressive success in some adult malignancies, in particular monoclonal antibodies that block the

August 28th, 2018|

ENCePP activities during EMA’s next phase of Business Continuity Planning, effective from 1st October 2018

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency (EMA), playing a key role in developing the principles and best practices for the planning, design, conduct and reporting of post-authorisation safety studies (PASS). These are referenced in the good pharmacovigilance practices (GVP) guideline on PASS.

August 28th, 2018|

Procedure for orphan medicinal product designation: an update

The European Medicines Agency (EMA), based on the opinions on orphan designation (OD) adopted by the Committee for Orphan Medicinal Product (COMP), has released a Guidance  for Sponsors to submit an application via the current existing submission process until 19 September 2018.  Nevertheless, starting from 19 June 2018 onwards, organisations seeking to apply to the

August 28th, 2018|

SAVE THE DATE – 3rd International Conference on Pediatric Nursing and Healthcare, September 21-22, 2018, Vancouver

The 3rd International Conference on Paediatric Nursing and Healthcare will take place on 21 and 22 September in Vancouver (Canada) and involve more than 250 attendees from 90 countries. The attending delegates include Editorial Board members of related International Journals. The theme of the 2018 Conference will be “Exploring Innovations and Latest Advancements in Pediatric

August 28th, 2018|

18th World Congress of Basic and Clinical Pharmacology in Kyoto

The 18th World Congress of Basic and Clinical Pharmacology (WCP2018) took place from July 1st to 6th, 2018, in Kyoto, Japan. The main theme of WCP2018 was “Pharmacology for the Future - Science, Drug Development and Therapeutics”. TEDDY was present at the event with a poster showing the first activities performed in the framework of

July 26th, 2018|

Paediatric Regulation workshop report of EMA: how to better apply the Paediatric Regulation to boost development of medicines for children

The European Medicines Agency (EMA) released the report entitled “How to better apply the Paediatric Regulation to boost development of medicines for children”, related to the multi-stakeholder workshop held at the EMA on 20 March 2018. The workshop was the occasion to discuss and identify ways to improve the implementation of the Paediatric Regulation, that

July 20th, 2018|

Workshop on the development of antimicrobial medicinal products for paediatric patients

On 21-22 June 2018, the European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the United States' Food and Drug Administration co-organised a workshop to discuss the development of antimicrobial medicinal products and in particular antibiotics for children. This provided the possibility for international regulators to explore with medicine developers, clinicians and clinical

July 20th, 2018|