The challenges of potency assay development for cell-based medicinal products in Europe

May, 2015
Regulatory Rapporteur

Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2

June, 2015

Regulatory Rapporteur

This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Keeping up with innovation: The challenge for regulators

March, 2015
SCRIP Regulatory Affairs

Big data, mobile health and synthetic biology: An overview of some of the changes and measures taken by regulators as they strive to keep up with the latest developments.

Modern Technology Transfer Strategies for Biopharmaceutical Companies

March, 2015
BioProcess International

An overview of the latest technology transfer strategies used by bio-pharmaceutical companies today.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 1

February, 2015

Regulatory Rapporteur

An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

European Medicines Agency (EMA)

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

Regulatory approval and market access: a winning combination for drug launch optimization

2014
SCRIP Regulatory Affairs

Having a combined regulatory and market access strategy is critical for a drug launch to be successful.

Patient reported outcomes (PRO)

In market access and payer evaluation of new drugs, patient reported outcomes are as important for payers as are other “quantitative” measures (Biomarker levels in the blood, survival, radiological

Disease risk-factor reduction claims (RDRC)

Possibly the highest level of medicine-like health claim that can be made on a non-drug product.

Foods for Special Medical Purpose (FSMP)

These are specially formulated foods that provide partial or complete nutrient requirements for post-operative convalescing patients or other nutritionally vulnerable subjects with specific medical

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