iSpeak Blog

Bringing Pharma Regulatory Exposure to the Singapore Region

Maurice B. Parlane, B Tech MIT
2019 ISP Asia Pacific Pharmaceutical Manufacturing Conference in Singapore - ISPE Pharmaceutical Engineering

The 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 conference in 2018 - 2018 ISPE Pharmaceutical Manufacturing Conference.

Managing and improving pharmaceutical quality within the Asia Pacific region brings with it some unique challenges. We have a large patient population and demographic spread with a wide range of medicinal product needs from vaccines and essential medicines for local consumption, to the rapidly growing economies who are demanding better and wider ranges of medicines for their communities and including countries and organisations looking to grow a competitive and sustainable export manufacturing sector.

Within this environment there is an appetite for and long history of traditional medicines wishing to align with modern quality practices, a rapidly expanding generic medicine industry and a thirst for development of sustainable and local new generation medicine capabilities; coupled with a young and inquisitive work-force seeking to understand best practice. The Asia Pacific region has largely aligned with PIC/S GMPs and regulatory thinking, but there are some unique challenges and pressures in adoption of these standards. A distinctly local approach is required to rise to this level and to do so ensuring availability and affordability of medicines in a sustainable manner.

Adoption of modern pharmaceutical quality practices and advancing these in the future requires collaboration, as to succeed industry needs to lead this journey. The regulators role is to establish a framework, but only industry as a whole can deliver on the challenge of establishing sustainable and compliant GMP standards.

Industry must develop a deep understanding of the drivers and factors that underpin what is good and how to effectively harness these behaviours. Industry and ultimately patients cannot afford waste and false starts will only serve to discourage efforts as costs outweigh benefits.

The conference is deliberately aimed at quality professionals and those interested in advancing pharmaceutical quality within the region. The list of regulatory authorities contributing is impressive, with senior representation from MHRA, US FDA, WHO, PIC/S, HSA, PMDA Philippines FDA as well as many ASEAN regulators. Additionally, we have attracted a number of international subject matter experts from industry and academia. The conference will offer not one, but three sessions with regulators, focusing on International regulatory hot topics, ASEAN regulatory updates and international GMP inspection trends.

These sessions will be interspersed between programs focused on subjects of high interest in the APAC region including Cleaning and Process Validation, Developments and best practices for Facilities of the Future, Effective CAPA, Data Integrity and Aseptic Processing.

From a personal perspective, I am excited that the organising committee and ISPE have managed to pull together a program of this quality with the number of international experts we have confirmed. There is a real thirst for knowledge and understanding in these subject areas in our region and it will be invaluable to have the opportunity to listen to and network with these individuals to confirm that development of pharmaceutical quality practices are on the right path in the Asia Pacific Region.

The 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will complement the popular regional Affiliate conferences held throughout the year, bringing further international content and providing providing an opportunity to reinforce those programs with familiar faces and a wider range of international experts– in particular regulatory exposure - to the region.

2019 ISPE APAC Pharmaceutical Manufacturing Conference

Conferences such as this one where leaders from industry, health authorities and academia come together in an environment focussed on collaboration provide an opportunity for honest and open dialogue, exchanging of ideas and experiences. For this reason alone, I would encourage you to attend.

Very few leaders from the region have the opportunity to attend the ISPE Annual Meeting & Expo in the US. When I have been to these meetings, it is clear that attendees come away with a renewed sense of enthusiasm and new ideas. I am confident this conference and future incarnations of it provide a local forum where this can occur. The event has been priced to ensure attendees from throughout the region can participate. 

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