Reform of pharma legislation: the debate on regulatory data protection
by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision…
The UK’s statutory scheme revision for branded medicines
by Giuliana Miglierini The amendment of the statutory schemeregulating the increase in pricing and consequent clawback payments of…
The proposals of the EU Commission for the revision of the IP legislation
By Giuliana Miglierini In parallel to the new pharmaceutical legislation, on 27 April 2023 the EU Commission issued…
Comments to the draft ICH guidelines Q2(R2) and ICH Q14
by Giuliana Miglierini The public consultation on the two draft guidelines ICH Q2(R2) on the validation of analytical…
What happens after IP loss of protection
by Giuliana Miglierini What does it happen under a competitiveness perspective once intellectual property (IP) protection for medicinal…
Trends in Drug delivery and Formulation
by Giuliana Miglierini According to the 2021 Global Drug Delivery & Formulation Report, signed by Kurt Sedo, Vice…