Regulatory

PE Magazine
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4) offers advantages in the consistent format of the registration dossier using the Common Technical Document (CTD). However, it does not deliver a comprehensive view of the overall manufacturing control strategy or a means of understanding and managing the quality of the product throughout its life cycle. As a result, several regulatory authorities that have implemented the CTD format have also insisted on supplementary quality summary documentation that exceeds ICH requirements, and, in effect, creates divergent expectations for chemistry, manufacturing, and controls (CMC) content. A single global quality overall summary (QOS) format could clearly convey a holistic view of a product’s control strategy and improve the efficiency and economy of the regulatory review of an application while providing a way for the applicant and reviewer to align on a product life-cycle management plan.
Features
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...
Features
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)1
  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality–M4Q (R1)...
iSpeak Blog
ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived...
iSpeak Blog
As the world’s second largest market for pharmaceuticals and accounting for 20% of global medical device sales with double digit annual growth, the Chinese market is poised to have a significant impact on expanding patient access to innovative therapies and combination products (CPs). 1
  • 1Chinese Medical Device Industry: How to thrive in an increasingly competitive market?
Training
Best & Brightest Quality & Regulatory Content from the 2021 Conferences 78 Presentations Featuring 46+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference...