Hi Korea 2017 Conference Speakers
|Session 2 - 10:15 - 12:00, Wednesday, August 23|
|Health Related Food Trends in Japan
Following on from the introduction of standards and rules for Foods for Specified Health Uses (FOSHU), for which safety and effectiveness are certified by a third party, and Foods with Nutrient Function Claims (FNFC), which are required to be foods that contain a certain amount of vitamins and minerals, the Foods with Functional Claims (FFC) standard was introduced in April 2015. This requires the labeling of the functions of food based on the submission of scientific evidence, and the FFC standard has been drawing a lot of attention from consumers. In this presentation, the latest trends regarding standards and rules in Japan will be introduced.
Topics and Trends in the Japanese Health Related Food Market
Many consumers purchase health-related foods through mail order and, increasingly, on-line shopping. The typical problems that occur in connection with such sales will be discussed. The presentation will also look at some examples of the functions that have been inspected, and related issues, following the introduction of the Foods with Function Claims (FFC) system. The presentation will also discuss consumer understating of function claims and the future outlook for FFC.
|Session 3 - 14:00 - 16:10, Wednesday, August 23|
|Understanding the opportunity: Markets, regulation and dynamics of the Middle East and North Africa region & Rising to the opportunity: Strategic approaches to successfully entering the MENA markets
The Middle East and North Africa region offers the most dynamic health care markets in the world: in fact, this region and Sub-Saharan Africa will be the last region to offer double-digit growth to pharmaceutical companies.
Growing populations, rising middle classes, increased government spending and some of the highest rates of chronic diseases globally will drive continued demand. However, the MENA expansion decisions often suffer from the perceived political and security risks, a lack of data and unclarity about regulatory and commercial requirements. The lecture will provide an overview of the region, its most important markets, key regulations in approval and reimbursement of drugs and practical approaches to entering and operating successfully in MENA.
Claudia Palme is a partner at consulting firm 55east and senior advisor in the global Life Sciences and Health Care industry, based in Dubai, UAE. Her engagements focus on new business models, emerging markets' expansion, growth and restructuring strategy and investment advisory. Claudia has spent 20 years in senior management in the pharmaceutical industry at Amgen and Novartis and in consulting at The Boston Consulting Group and booz & company across Europe, the Middle East, Africa and Latin America. Before setting up 55east in 2014, she led Strategic Planning and Operations for the Middle East and Africa region at Amgen.
|Session 4 - 10:10 - 11:15, Thursday, August 24|
|WHO Prequalification Programme: Opportunities for Drug Product and API manufacturers.
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.
Dr Antony Fake has worked with the WHO Prequalification Team since 2010. He is the focal point for API-related assessments within the Prequalification Team – Medicines Assessment (WHO), based in Geneva. This includes oversight of the API Prequalification procedure and API assessment in support of Finished Pharmaceutical Products seeking Prequalification.
He is currently Co-chair of the International Generics Drugs Regulatory Programme, Quality Working Group and recently participated in the ICH Q11 Q&A working group.
Before joining WHO he was Team Leader Prescription Medicines at the New Zealand Medicine Regulator (Medsafe) in 2000. He is a Chemist by training. .