Pharmaceutical Regulatory Summit Asia

Experts Speakers Include:

  • Michel Mikhail Chief Regulatory Officer, Executive Vice President, Global Regulatory Affairs, Fresenius Kabi, Germany

    Joy Chen Director, Regulatory Affairs, Reckitt Benckiser, Singapore

    Ariel Valencia Deputy Director, Food & Drugs Administration, Department of Health, Philippines

    Lejun Pang Senior Researcher, Shanghai Institute for Food and Drug Safety, Shanghai FDA, China

  • Stefano Accorsi Director, International Regulatory Affairs, Global Regulatory Affairs, Chiesi Farmaceutici, Italy

    Prof. Jack Wong Director, Regulatory Affairs, Terumo BCT, Secretariat in Asian Harmonization Working Party (AHWP)

    Reinhard Berger Senior Expert, Federal Office for Safety in Healthcare, Austrian Medicines and Medical Device Agency (AGES)

    Duu-Gong Wu Director of Regulatory Consulting, PPD, former US FDA Deputy Director, USA

Meeting Regulatory Expectations for Fast Product Approvals

The 7th Pharma Regulatory Affairs Asia conference brings together both regional and international regulatory experts to discuss the regulatory trends, challenges and perspectives in Asia.

By attending this conference you will be able to tackle the region’s changing and complex regulatory landscape and formulate strategies to access and penetrate the Asian pharmaceutical market.  New topics on innovative drugs, novel drug delivery systems, and medical devices will be introduced this year.

Top 5 Reasons to Attend

  • Understand what is required and expected of a regulatory submission in Asia
  • Analyze Asian regulatory trends for strategy development
  • Gain insights into Asia’s innovative drugs and medical devices regulatory landscape
  • Know the latest regulatory initiatives from South East Asia
  • Meet and network with regulatory experts and peers in this value packed 4 day event

Key Themes for 2014

  • Key Asian regulatory trends , perspectives and their impact on R&D
  • Innovative product & biologics regulatory guidelines
  • South East Asian product quality and stability requirements, regulations and implementation
  • Asia’s medical device quality, clinical trials and classification regulatory landscape
  • Post approval variations and its requirements in ensuring quality and safety

About PharmaCon

The Pharmaceutical Congress Asia recognizes the importance of strong partnerships to drive innovation, development and winning products and services in Asia’s growing pharmaceutical industry. Packed with case studies from market leaders, four agendas will unite to create a hub of research, innovation, improved regulatory frameworks, best practice business, marketing and distribution models that will define Asia’s pharmaceutical future.

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