Pharmaceutical Bio Association Launches Webinar to Support European Market Entry

The Korea Pharmaceutical and Bio-Pharma Manufacturers Association announced on the 26th that it will hold an online (Zoom) ‘Webinar on Entering the European Pharmaceutical Market’ over two days from the 2nd to the 3rd of next month to support accelerating entry into the pharmaceutical markets of the 27 European Union (EU) countries.

Webinar Poster for Entry into the European Pharmaceutical Market
Photo by Korea Pharmaceutical and Bio-Pharma Manufacturers Association

The EU pharmaceutical market, valued at approximately 300 trillion KRW, is considered an important market accounting for 25% of the global market. However, due to a complex system requiring different approval procedures such as centralized, individual country, and mutual recognition processes depending on the type of medicine, the entry barriers are regarded as high. In particular, since the unified European Clinical Trials Information System (CTIS) was introduced in January, and the European unitary patent application system will be implemented from June, preparations for entering the EU market are becoming increasingly demanding.

CTIS is a clinical trial management system that improves the previous disadvantage of submitting clinical trial applications separately to the competent authorities of each European country by allowing a single application to request clinical trial approval in 30 European Economic Area (EEA) countries. The European unitary patent system allows patent protection in EU countries with a single registration at the European Patent Office (EPO), and as of February, 17 EU member states including Germany, France, and Italy have ratified it.

On the first day of the webinar, Daniel Semere, Head of Global Regulatory Affairs (RA) at OPIS, the largest clinical research organization (CRO) in Europe, will present ▲trends in European pharmaceuticals and approval systems ▲trends in European pharmaceutical clinical trials, and discuss important considerations and effective strategic plans for entering the European market. On the second day, patent experts Robert Andrews and Hojae Lee, patent attorneys from the UK-based law firm Mewburn Ellis, will present on ‘Understanding the European Pharmaceutical Patent System,’ focusing on exclusive rights of local pharmaceuticals in Europe. They will especially provide detailed explanations of the newly introduced European unitary patent system.

A representative from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “We hope this webinar will help understand the complex approval systems of EU countries and assist in entering the European market,” adding, “It will be an opportunity to enhance understanding of the newly introduced European Clinical Trials Information System and the overall European market starting this year.”

This webinar is free to attend for anyone interested in the European pharmaceutical market through prior registration. Korean-English simultaneous interpretation will be provided for efficient information delivery. Detailed information and pre-registration can be found on the association’s official website.

This content was produced with the assistance of AI translation services.