iSpeak Blog
2019 ISPE APAC Pharmaceutical Manufacturing Conference
Regulatory Insight on Drug Discovery, Approvals, and Inspection Management
Regulators play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. Securing first-hand regulatory insight gives you the advantage to make informed decisions and optimal regulatory strategies. At the 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference, you’ll have the unique opportunity to tap into the minds of global regulatory decision makers in drug discovery, approvals, and inspection management.
Our line-up of global regulatory leaders will share their insight and perspectives to help you to proactively prepare for challenges, minimize risks, and maximize quality. Don’t miss your chance to get unparalleled access to global regulatory and quality intelligence, including more than 20 presenters and attendees from these organizations:
- MHRA
- WHO
- USFDA
- Philippines FDA
- PIC/S
- PMDA
- Singapore Health Sciences Authority
Rounding out our dynamic presenter line-up are experts from leading industry organizations, such as Novatek International and Takeda Pharmaceutical, and academia, including as the University of Tokyo—giving you comprehensive industry insight you can’t get elsewhere.
Regulatory Topics from Around the World
- PIC/S GMP Inspection Reliance Initiate
- Quality Culture and Inspectional Findings
- Quality Risk Management and Inspectional Findings in the Global Environment
- Facilities of the Future: An Exploration of Pharma 4.0 and Continuous Manufacturing
- WHO experience in Prequalification GMP Inspections in India and China
- Quality & Compliance
- Managing Root Cause Investigations
- Cleaning Validation and Process Validation
- Data Integrity for Manufacturing
Conference Highlights
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Pharmaceutical manufacturing sites that export their products around the world are often subjected to many GMP inspections each year by different regulatory authorities, with a significant number of these being duplicate, same-scope inspections. This is...
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iSpeak BlogAsia Pacific Pharma Outlook The healthcare market in the Asia Pacific (APAC) region is continuing to grow at a steady rate with an estimated 500-billion-dollar industry by 2020. This is due to rising development in smart manufacturing and government... -
iSpeak BlogThe 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will be held 30 September to 1 October in Singapore. The conference is modelled on the regional ISPE conferences held in North America and Europe each year and follows a successful pilot...
Learning Objectives
- Become current on industry trends in quality & quality risk management
- Understand quality and regulatory requirements and expectations
- Address the recent developments and innovations in manufacturing
- Understand the necessary elements for on-going quality sustainability
Who Should Attend
- Regulatory Affairs Experts
- GMP Inspectors
- Quality Assurance Experts
- Quality Operations Experts
- Executive Level Leaders in Pharmaceutical and Biomanufacturing
- Pharma Senior Level Manager
Commitee Members
Board Ambassador
