Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.

Marketing Authorization Application (MAA)

The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.

Clinical Trials in the EU/EEA- Focus on CMC Aspects

Pharmaceutical Outsourcing

Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC [1]. This has led to different requirements amongst the Competent Authorities (CAs) and Ethics Committees (ECs) of each concerned MS.

Designing a CMC strategy for advanced therapy medicinal products in EU

SCRIP Regulatory Affairs

Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products.

Quality by design: a beginner’s guide

STP Pharma Pratiques

Quality by design (QbD) is becoming increasingly utilized as a valuable tool for focused and efficient drug development. Centering on case studies, we will look at how QbD can be used in its application to small molecules and biopharmaceuticals.

US&EU Regulations for drug delivery systems: development considerations for innovate products

SCRIP Regulatory Affairs

Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers.

Considerations on paediatric investigation plans for advanced therapy medicinal products,TOPRA Vol 8, No.10

Regulatory Rapporteur

In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must therefore obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA).

Building an affordable innovative drug development chain

Express India

Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and technical contributions not only help us to remain updated but also aware of the philosophy underlying new regulations. Dr Emmanuelle Voisin, CEO, Voisin Consulting spoke on the trends in regulation and how India fits into her plans to build an affordable innovative chain, from discovery to market.