Pharmaceutical News and Updates
-
EMA meets industry stakeholders on scientific advice and clinical trial coordination
On 3rd July 2025 EMA conducted its annual meeting with representatives of industry stakeholders to address topics of evidence generation along the medicine’s life cycle and related product-development support activities, such as scientific advice…
-
CTA Applications in Europe
What distinguishes Pharma Design from other service providers is that we offer cost-saving, targeted and dedicated support with a team of very specialised consultants. Our prices are competitive thanks to our lean and flexible business…
-
Serious clinical development players should avoid ‘hype’ and ‘hope’
Hype and hope are markers of bias and should be excluded from the scientific method. This approach has been obvious since the 19th century, when the most ‘revolutionary’ early researchers have been skeptical about their…
-
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, so stop calling them so.
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, therefore the very sexy terminology of ‘cancer vaccines’ is inappropriate. MHRA’s clarifies own definitions (https://assets.publishing.service.gov.uk/media/6799ef4d9a6dc0352ab34225/Individualised_mRNA_cancer_immunotherapies_0.6.5.pdf). More appropriately, MHRA states that such products are individualised…
-
We are hiring a business manager
We are looking for a business manager to work up to 3 days a week, from anywhere in the UK on a contract basis. RequirementsSignificant experience in the pharmaceutical services sector (Regulatory Affairs, Pharmacovigilance, Clinical…
-
EMA/HTA parallel consultation platform
On 30 June 2017 the EMA and EUnetHTA launched the new EMA/HTA parallel consultation platform. The new guidance replaces the former draft best practice guide as of publication date and has been developed from the experience gained with the SEED…
-
Update to Orphan Product MAA variations
On November 18, 2016, EMA published an update to the post-authorisation guidance on MA extensions and type II variations to include further details on the information companies need to provide when submitting a Type II variation…
-
The public consultation on Europe’s Paediatric Regulation
The Paediatric Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products) was adopted in 2007 to address a serious gap in knowledge on…