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EMA anticancer drug recommendations for approval in 2017

EMA anticancer drug recommendations for approval in 2017

23 January 2018, Julia Holland, Consultant & Kun Shi, Consultant

In 2017, the European Medicines Agency (EMA) made a total of 92 positive recommendations to the European Commission for medicines to receive marketing approval. Approximately one fourth (23/92) were aimed at cancer treatment, which almos...Read more

No child should die of cancer: paediatric oncology trials in Europe and USA

No child should die of cancer: paediatric oncology trials in Europe and USA

12 December 2017, José Matamoros Luna, Clinical Data Manager

Paediatric oncology has in general been one of the most successful areas of oncology where current treatments can achieve good efficacy and long term survival. However, this is still not the case for a significant number of children suff...Read more

Are you ready for the new EudraVigilance System?

Are you ready for the new EudraVigilance System?

1 November 2017, Canan Karakaya, Pharmacovigilance Manager

The new system has implications for all users of the EudraVigilance system, such as National Competent Authorities, Marketing Authorisation Holders and Sponsors of clinical trials. All users have to ensure that their processes and local...Read more

CICON2017: Translating Science into Survival #3

CICON2017: Translating Science into Survival #3

20 September 2017, Julia Holland, PhD

Over the week we will publish a blog mini-series of each day's key highlights from the Third CRI-CIMT-EATI-AACR (CICON17) International Cancer Immunotherapy Conference: Translating Science into Survival (September 6-9, 2017 in Mainz/Fran...Read more

CICON2017: Translating Science into Survival #2

CICON2017: Translating Science into Survival #2

19 September 2017, Julia Holland, PhD

Over the week we will publish a blog mini-series of each day's key highlights from the Third CRI-CIMT-EATI-AACR (CICON17) International Cancer Immunotherapy Conference: Translating Science into Survival (September 6-9, 2017 in Mainz/Fran...Read more

CICON2017: Translating Science into Survival #1

CICON2017: Translating Science into Survival #1

15 September 2017, Julia Holland, PhD

Over the week we will publish a blog mini-series of each day's key highlights from the Third CRI-CIMT-EATI-AACR (CICON17) International Cancer Immunotherapy Conference: Translating Science into Survival (September 6-9, 2017 in Mainz/Fran...Read more

The year after; was the CRA-academy really the gateway to become a great CRA?

The year after; was the CRA-academy really the gateway to become a great CRA?

22 June 2017, Alicia Veerman MSc, Clinical Research Associate

So here we are again, already more than a year later since we participated in SMS-oncology's first CRA-academy. Might sound cliché but time indeed seems to fly when you are having fun. We certainly enjoyed the past year, and more importa...Read more

Compassionate Use: providing cancer care outside trials

Compassionate Use: providing cancer care outside trials

2 May 2017, Fleur Eeman MSc, Clinical Research Associate & Jasmijn Hubers MD PhD, Medical Monitor

Being a challenging and arduous operation, finding new therapies to treat cancer often is a time-consuming process. For some patients, marketed therapies are to no avail, while at the same moment new optional therapies are on the way to...Read more

The changing landscape of oncology clinical trials - AACR 2017

The changing landscape of oncology clinical trials - AACR 2017

14 April 2017, Nadina Grosios PhD MPH, Director Consultancy

The 2017 annual meeting of the American Association for Cancer Research (AACR) could not start any better. A fascinating plenary session included Angela Belcher (Massachusetts Institute of Technology) and Bert Vogelstein (Sidney Kimmel C...Read more

EMA anticancer drug recommendations for approval in 2016

EMA anticancer drug recommendations for approval in 2016

27 January 2017, Canan Karakaya, Pharmacovigilance Manager & Nadina Grosios, Director Consultancy

Among the 81 medicines recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) in 2016, there were 13 recommendations made for novel oncology products, just slightly down from 16 in the previous year. These...Read more

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