Agenda

All times displayed for Asia/Seoul timezone.

PMDA

Experience of GMP inspection at PMDA and future perspective of GMP in Japan
10:15 - 10:55
Conference

Sponsored by:

Since we joined PIC/S, which is pharmaceutical inspection co-operation scheme consisting of Europe and the United States and the other major countries, at the same time as Korea in July 2014, PMDA?s Office of Manufacturing/Quality and Compliance has been conducting GMP inspections in line with international standards.

In the light of present situation surrounding Japan, with the aim of contributing to the international harmonization of the GMP ministerial ordinance and further strengthening the quality assurance system at the manufacturers which medicinal products distributing in Japan, we began to consider revision of the GMP ministerial ordinance incorporating with the latest international standards since FY 2016 and summarized the final draft.

This presentation will cover GMP inspection experience of PMDA including introduction of examples of critical/major observations we found and future perspective of GMP in Japan including introduction of proposed revision of the GMP ministerial ordinance.

Practical examples with Q&A
11:10 - 11:50
Conference

Sponsored by:

EAS Strategies

Claims for Foods in the European Union: Key Regulatory Features
13:30 - 14:10
Conference
Manager, Food Law
EAS Strategies

Sponsored by:

EU rules on nutrition and health claims have been established by Regulation 1924/2006 which started to apply in 2007.
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EAS Strategies will provide a snapshot of the EU regulatory framework surrounding claims on foods, in the product label or in its advertising.
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This session will highlight the key regulatory features, the types of claims, the authorisation procedures and the status quo of what is authorised and prohibited in the EU.

Claims for Foods in the EU: Regulatory Checklist
14:25 - 15:05
Conference
Manager, Food Law
EAS Strategies

Sponsored by:

EAS Strategies will guide participants through the do?s and don'ts when making a new claim for a food to be marketed in the EU.
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With practical cases, this session aims to give a checklist and provide clarity on how to communicate about the properties of foods in the EU, to consumers directly but also to businesses or health care professionals.

World Health Organisation

WHO Prequalification Programme, Opportunities for Drug Product and API manufacturers
15:30 - 16:30
Conference
API Focal Point, Prequalification Team –Medicines
World Health Organisation(WHO)

Sponsored by:

The WHO Prequalification Team provides advice to UN agencies and international medicine procurers on the quality, safety and efficacy of purchased medicines. In most cases, eligibility for procurement requires the medicine to be either approved by a Stringent Regulatory agency or prequalified by the WHO Prequalification Team.

This presentation will provide an introduction to the medicine and API prequalification programme including: who may apply, what are the requirements and procedures. The possibility for arranging technical assistance to potential manufacturers who wish to participate will be outlined.

Finally, the presentation will also introduce the WHO collaborative procedure. This is a procedure introduced to significantly reduce national registration times for prequalified products, allowing sales of the medicine to the local market quickly. The procedure requests a decision from the national medicines authority within 90 days. Nearly 30 countries are now participating in this scheme.