European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.

European Directorate for the Quality of Medicines (EDQM)

The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from 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.

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

2012
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

2011
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

2009
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.

European Biotech sector struggles to survive funding crisis, Monthly, June 2009

2009
The Center Watch

One in five European small biopharmaceutical companies faces the rick of bankruptcy by the end of 2009. the situation could worsen if the economic downturn continues into 2010, warns the European Biopharmaceutical Enterprise (EBE).

Pharmacokinetics

2006

As for chemicals, the development of numerous biopharmaceutical products has been accompanied during the last 15 years by a sustained and joint effort of the Regulatory Authorities and the Industry to set up contributory
regulatory guidelines.

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