Welcome in the new year and we hope you enjoyed the festivities of the holidays.
We wish to thank our 2016 Committee for their support in our busiest year so far.
It's not too late to join the new committee, with nominations accepted for the AGM on 19 January. We look forward to meeting you and expect a full house as attendance has topped 70 already, a new record!
Judging from participation in last year's events, we recommend that you block your dates early, whether for educational, training or socials. Our programme continues to grow as we aim to provide more opportunities for learning and sharing of experience. We're also pleased to highlight our regional affiliates' news and upcoming events, to which you're invited if your travel plans allow.
Best Wishes,
from your ISPE Singapore Affiliate
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Herny Prasetya
(pictured on the top left)
ISPE Indonesia Affiliate, Chair
Indonesia
's pharmaceutical market is fast growing, valued at less than USD 3 million in 2008, to USD 7 million in 2015 and projected to reach USD 12 million in 2016. One of the factors influencing this is the national health insurance implemented by the government. Serving 122 million Indonesian citizens in 2014 to a targeted 259 million in 2019, it will become the world's largest insurance coverage.
This will require a new strategy for the pharmaceutical industry in terms of volumes required from their existing manufacturing facility and a balance of price of product and compliance to quality. The growth of product demand is reflected in expansion of existing facilities alongside new investment from local (new players) as well as joint foreign-local investments.
The increase of volume produced, product portfolio as well as additional players in Indonesia's pharmaceutical industry will require enhancement in the institutional capacity of the Indonesian National Agency of Drug and Food Control, including the number of inspectors. At the end of 2015, NADFC has started to increase maturity in GMP compliance level of pharmaceutical companies, requiring that GMP compliance become a need and part of company culture. The final aim of this project is to implement a risk based regulatory inspection frequency based on company maturity level.
As part of NADFC public service, post market product control/surveillance is done through sampling and testing of product available in the market (downstream). This control is lately further enhanced by taking and testing of upstream sample (taken directly from the production line) to ensure quality of fresh product.
In 2016 ISPE Indonesia has assisted industry, with seminars and workshops on the importance of corporate culture in building compliance and how to build quality manuals. In 2017, we will continue our efforts, specifically on human development and data integrity. During our 2017 annual conference we will dedicate a plenary session and track to discuss data integrity, with a breakout track for human development.
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Interview with...
Ronan McGarvey
Director, Quality Operations, Biologics Quality Assurance
AbbVie Operations Singapore Pte. Ltd.
ISPE SG: What brought you to Singapore?
RM:
The timing was right for my family and career to take on an International move. AbbVie were investing in Singapore and the combination of Start up, Biologics, Small molecule pipeline and Asia made it very interesting.
ISPE SG: How does your experience here compare with your previous postings?
RM:
Previous to Singapore I had spent my entire professional career working in Ireland. There are many comparisons when it comes to the educated workforce and the pro Industry policies of the Government. Ireland also has a cluster of Pharma and Biopharma MNC and is a relatively small country too.
ISPE SG: What do you enjoy about working/living here?
RM: Singapore
has the energy and nascent feel of a young country. Although we work in a highly regulated business, in Singapore and in Asia in general there is the opportunity to shape where the industry is going. It's a great time to be involved whether in Manufacturing, Service provision or Supply.
The family love living here, before we came we thought moving from a Bungalow to a Condo would be very strange and that we would never get used to the climate. I am impressed at how well the family adjusted and what a safe and fun country it is for them.
ISPE SG: Anything else that you'd like to share with our readers?
RM:
I admire how well ISPE fills the space between Engineering and Quality/ Compliance. I encourage young professionals to get involved and always remember that any day you are learning is a good day.
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by Carin Siow, 
winner of the 2016 ISPE Singapore Student Poster Competition
In September 2016, as winner of the ISPE Singapore Student Poster Competition,
I was given the opportunity to attend the ISPE Annual Meeting in Atlanta, Gerogia to present my work at the student poster competition. Though I did not win, I was humbled and heartened to receive feedback and positive comments about my work from the judges and industrial players. This provided a form of validation and affirmation, and reinforced the spirit of conferences like these, which offers great opportunities to glean precious knowledge from the experts in the field.
Coming from a background that previously dealt more with the clinical aspects of pharmaceutical products, I am extremely thankful for the chance to catch a glimpse of the engineering perspectives pertaining to R&D, manufacturing, validation and regulatory in the pharmaceutical industry. Like many other student participants at the conference, we felt like we have received so much more than what we could ever learn in school. Not only is the knowledge current and in tandem with my research work, I am certain that this will also serve as a valuable experience for the future. The networking sessions at the conference were definitely a good platform for interaction with experts from different areas of the industry.
Throughout the conference, there was a lot of emphasis on the Young Professionals and the nurturing of Young Professionals was one objective set by ISPE at the annual meeting this year. In my opinion, such support from the community not only helps to mentor new leaders, but also helps provide a strong network in the pharmaceutical industry. This is something worth emulating and greater awareness about the benefits of ISPE should be propagated, particularly to students with a keen interest in working in the pharmaceutical industry. Nevertheless, I am deeply grateful to ISPE Singapore for the chance to represent Singapore on an international platform, and also to Miss Kristina Autenrieth (ISPE Singapore Affiliate Manager) for all the help rendered. Without this sponsorship, I would have lost out on this great opportunity and for this, I am truly thankful.
This year's Student Poster Competition will be a Regional Contest, with finalists selected from the region and invited to present in the Final at the annual ISPE Singapore Conference & Exhibition. Entry details and submissions will be posted by regional affiliates early this year.
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Practical Containment and Sampling
NUS Blk E3, Engineering Drive 3, Level 6, Unit 1,
Room E3-06-01
ISPE Singapore AGM 2017 & Networking Dinner & Drinks (Sold out!)
Genting Hotel Singapore
A new Executive Committee will be elected. If you are interested in a volunteer position, please contact
Kristina
Thank you to our sponsors No deviation, PM Group and Steris
7 & 10 Feb 2017 | 10am-6pm
Multi-Purpose Sports Hall, NUS
We need your help! Contact Kristina if you are able to join us in the exhibit hall, to share your tips, experience and raise awareness of careers in the industry. 9,000 students are expected to attend over the 2 days.
Designing A Risk Based Cleaning and Disinfection Programme
6 Mar 2017 | 9am-4pm
Genting Hotel Singapore
Hosted by STERIS Corporation, following the successful seminar in 2016. This informative training has been extended to 1 day for more detailed and in-depth presentations.
21-23 March 2017
ISPE Singapore will feature speakers in the main exhibition programme.
Click here for registration and details
BioBiz 2017
1 Apr 2017
Suntec Singapore
ISPE Singapore will exhibit and provide feedback to students in the CV Clinic at this annual event, attended by Singapore's universities and polytechnics. Volunteers needed to man the stand! Please contact
Kristina if you can help.
ISPE Singapore Conference & Exhibition 2017
23-26 Aug 2017
Suntec Singapore
Click here for more information
Contact us if you'd like to include your
event here.
(Postings are vetted according to ISPE guidelines on commercial content and subject to approval by the committee.)
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ISPE Thailand Affiliate GMP Pharmaceutical Facility Design
16 Feb 2017, Ambassador Hotel Bangkok, Thailand
ISPE Australasia GAMP Data Integrity
27 Feb 2017, Melbourne City Convention Centre
1 Mar 2017, Johnson & Johnson, Sydney
ISPE Australasia Statistics for Validation
23 Mar 2017, Holiday Inn Auckland
19 Apr 2017, Johnson & Johnson Sydney
20 Apr 2017, Melbourne City Convention Centre
ISPE Australasia Process Validation
1-3 May 2017,
Pullman, Sydney Olympic Park
ISPE Indonesia Affiliate Annual Conference
9-10 May 2017, Jakarta Indonesia
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Recruitment:
Young Professional Executive
ISPE Singapore is looking for a young professional to join the team, on a full time basis.
Responsible for supporting the association in communications, social media and organization, the ideal candidate will possess a scientific and/or engineering education and preferably some work experience.
For a job description and to apply, please contact Kristina
Interested in PAT?
Join our exclusive
PAT CoP Email-List and find out about all upcoming PAT related activities.
Join our Executive Committee in 2017! Contact
Kristina for more information.
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
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