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Hi Korea 2018 Conference Speakers

Inspector, PMDA
Session 1  - 10:15 - 11:50, Tuesday, August 28
Speaker Profile:
Pharmaceuticals and Medical Device Agency Office of Manufacturing/Quality and Compliance Division of Pharmaceuticals
2017.4- Present
2015.1- Ministry of Health, Labour and Welfare
2011.4- Pharmaceuticals and Medical Device Agency Office of Manufacturing/Quality and Compliance Division of Medical devices

Bachelor of Pharmaceuticals and Master of Pharmaceuticals from The University of Tokyo(Japan)
Introduction of the Lecture:
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.

Elodie Lebastard
Manager, Food Law, EAS Strategies
Session 2  - 13:30 - 15:05, Tuesday, August 28
Speaker Profile:
Elodie Lebastard is Manager Food Law at EAS Strategies, European office, providing regulatory and strategic advice at the EU and national levels. Elodie is a lawyer specialised in food law (University of Nantes – France, and University of Zaragoza – Spain).

Before joining EAS in 2008, she worked as a regulatory affairs consultant in France, and has completed a traineeship at the European Commission, DG SANCO, Food Law, Nutrition and Labelling Unit, working on food supplements and nutrition labelling EU regulations and policies.

She advises clients on classification of products, status of ingredients, labelling compliance, nutrition and health claims, marketing procedures and provides specific advice on the mutual recognition principle across the EU. Elodie has spoken at numerous European and international conferences on food supplements, dietetic foods and functional foods.
Introduction of the Lecture:
Part 1.
EU rules on nutrition and health claims have been established by Regulation 1924/2006 which started to apply in 2007.

EAS Strategies will provide a snapshot of the EU regulatory framework surrounding claims on foods, in the product label or in its advertising.

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.

Part 2.
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.

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.

Dr. Antony Fake
API Focal Point, Prequalification Team –Medicines
World Health Organisation(WHO)
Session 3  - 15:30 - 16:30, Tuesday, August 28
Speaker Profile:
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.
Introduction of the Lecture:
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. Ajaz S. Hussain
Insight, Advice & Solutions, LLC (USA)
Session 4  - 10:15 - 11:50, Wednesday, August 29
Speaker Profile:
Dr. Hussain distributes time between his consulting practice ( and his role as the President of the National Institute for Pharmaceutical Technology and Education ( He trained as a pharmacist at the Bombay College of Pharmacy, India; and received his Doctoral degree from the University of Cincinnati.

His career path is diverse – academician, US FDA regulator, senior executive (in pharma and tobacco sector) and now an advisor and consultant with support for academia. He is passionate about making high pharmaceutical quality affordable and shares his view on the topic around the world and on his LinkedIn page (
Introduction of the Lecture:
Part 1.
In the USA, increasing competition via generic and biosimilar drug product approval after the expiration of intellectual property and other exclusivity claims is the preferred path to reducing the price of drug products. Automatic substitution at the pharmacy level via FDA certified interchangeability designation is an essential component of this process.

Establishment of Therapeutic Equivalence via evidence based on analytical characterization, pharmacokinetic assessment of bioequivalence and minimal reliance on comparative clinical assessment is the preferred evidentiary criteria. For complex generics and interchangeable biosimilar products, the concept of "totality of evidence" is an important concept and consideration.

As of this writing, no biosimilar product approved in the USA has been designated as interchangeable. Approval of complex generic products remains a slow and uncertain process. This presentation will elaborate on these technical and regulatory challenges and discuss essential considerations to overcome these challenges.

Part 2.
The US FDA generic and biosimilar products are regulated under two different statutes (the FD&C Act and Public Health Service Act) and managed within the Center for Drug Evaluation and Research.

This presentation will overview the FDA current processes for the pre-approval, and routine CGMP inspections for complex generic and biosimilar products are and discuss deficiencies being noted. The impact of CGMP deficiencies on regulatory approval decisions will be examined and ways to minimize adverse regulatory impact discussed.

Marieke van Dalen
Global Regulatory Specialist, Aspen Oss B.V.,
Active Pharmaceutical Ingredients Committee(APIC)
Session 5  - 13:00 - 14:35, Wednesday, August 29
Speaker Profile:
Mrs. Marieke van Dalen works as the Global Regulatory Specialist for Aspen Oss B.V., a company located in the Netherlands, producing a wide variety of APIs. These APIs are sold on a global scale and thus registrations are supported in many regions of the world.

Marieke is also a Board Member of APIC (Active Pharmaceutical Ingredients Committee), which is the Technical European Industry Association for API producers, based in Brussels. She often represents the European API industry in meetings with health authorities and in the Observers meeting at ICH.
Introduction of the Lecture:
The regulatory world is constantly changing. As is the case in other parts of the world, Europe is closely following ICH guidance. Recent developments in Europe related to API's from the ICH side are the implementation of ICH Q11 and ICH Q3D. In the second part of the presentation the Q3D topic will be dealt with in greater detail.

A non-guideline Europe specific topic that has come up in Europe is the Brexit (UK leaving the European Union). This also impacts the position of the UK in e.g. the Euopean Medicines Agency and the EU-approved medicines on the UK market.

Dr. Claudia Lin
Suzhou AABioQ Pharmaceuticals Co., Ltd. (China)
Session 6  - 15:00 - 16:35, Wednesday, August 29
Speaker Profile:
Dr. Claudia Lin is a China 1000 Innovation Talent Award recipient. She obtained her Ph.D degree in Cell and Molecular Biology from University of California at Berkeley. For the past 15 years, her career has been focused on CMC, manufacturing and Quality.

Dr. Lin held various Quality leadership positions in Genentech/ROCHE including QA and QC functions for clinical development, as well as technology transfer and Annual Product Quality Review for ROCHE global commercial biologics portfolio. Afterwards, she was head of Quality Assurance for Bayer Healthcare Biotech division in California, responsible for all products in clinical development.

She was also involved in the work of global leading monoclonal antibody products listing. When Dr. Lin first came back to China in early 2015, she worked as senior executives at two leading Chinese biopharmaceutical companies, responsible for GMP compliance, Quality management and product development. In May last year, Dr. Lin founded Suzhou AABioQ Pharmaceutical Co., Ltd. -- Contract Quality Organization (CQO), providing biopharmaceutical enterprises with comprehensive CMC quality management services.

Andrew Akitson
Marketing Manager
China Skinny
Session 7  - 10:15 - 11:50, Thursday, August 30
Speaker Profile:
Andrew has been involved with China culture and trade since 2010. During his tenure at China Skinny he has led a number of projects in food & beverage, health & nutrition and healthcare. As the editor of China Skinny's internationally-renowned newsletter, his depth of knowledge ensures his place as an expert on the China market. He is a well-regarded speaker about the China market in both China and internationally.
Introduction of the Lecture:
Part 1.
China's health food market is a frantic space - on one hand businesses need to keep track of regulatory changes for the claims they make and on the other, do they make a difference with consumers? This session introduces some of the most relevant regulatory factors for making health food claims and some much needed context to understand what resonates and market perception.

Part 2.
An engaging look at market trends and developments any business hoping to tackle China's health food market should be aware of. Whether it is newly-emerging channels or burgeoning industry opportunities, China offers a diligent brand many avenues to gain a foothold in an increasingly competitive market.