SHARE:  







 Quarterly Newsletter
Jul 2019                                                                                                            Issue #15

"The bad news is time flies. The good news is you're the pilot." - Michael Altshuler
"Time flies when you're multitasking."  - Bert McCoy
"Time limits, make each moment count."  - Martin Uzochukwu Ugwu

Just some of the many quotes relating to that most precious resource.

Whether in our professional or private lives, we juggle numerous priorities and demands for our time. How we judge, adapt and balance this has an impact on our 'success', whichever way you define it.

So as we pass midyear, how are you doing? Not too badly? Room for improvement? Well, we hope that you'll spend some of your time, connecting with friends, colleagues and new contacts, at our upcoming events and particularly our annual conference in August. We look forward to meeting you and spending some valuable time together!

Best regards,
Your ISPE Singapore Affiliate
Guest Editorial
Totsapon Santitewagun
Chair, ISPE APAC 2018/2019 & President, ISPE Thailand Affiliate

It's halfway in my term as ISPE APAC Chair time after I took this tenure in November 2018 at ISPE's annual meeting in Philadelphia.

I have learnt many things as ISPE APAC Chair. In this role, I have led the APAC  community, which mostly comprises of emerging economy countries  into global communities. We have some constraints, especially the cost of living difference in relation to global activities. In this regard, we try to make it work by sharing these costs, such as ISPE training course among our APAC countries.

I think it is vitally important to have an effective collaboration among APAC leaders. Therefore, I have started the culture on joining each other's country at their annual meeting. I have attended ISPE Indonesia Affiliate's annual meeting 2019 and will attend ISPE Singapore conference 2019 too. We have teleconferences every two months and recently held the APAC face-to-face meeting in my country (Thailand). I have to ensure that there is full participation at meetings, all relevant matters are discussed and that effective decisions are made and carried out. Here are some of my observations or learnings:
  • Co-operation among APAC countries
  • Create a culture on joining other countries' annual meeting
  • Bringing more ISPE standard training courses
  • Clarification on official local trainers
  • Promote student chapter activities 
Last but not least, create the mindset that we are all in the same family of ISPE Asia Pacific region.
Report from
Taiwan Seminar on Modern Technologies in International Pharma, 
15 April 2019
Thomas Terranova
ISPE Singapore Affiliate, Member Services Committee Chair (2019),
Managing Director, Terra Asia Consulting Pte Ltd

This seminar was hosted by CPMDA, the Taiwan Pharmaceutical Manufacture and Development Association (TPMDA), with support from ISPE Singapore Affiliate. Almost 100 people attended the full-day event in Taipei, Taiwan. Participants included representatives from the government and public sectors, domestic pharmaceutical, biopharma and medical devices industry, equipment and technology as well as services providers. Most of the attendees from pharmaceutical companies came from the areas of engineering and technical services and had at least 10 years of industry experience.
 
Opening speeches by the TPMDA and the Taiwan Food and Drug Administration (TFDA) were followed by an introduction by ISPE Singapore Affiliate and presentations by leading industry experts. Topics covered diverse areas like facility design, single-use technology, continuous manufacturing, serialization and digitization with extensive and lively Q&A sessions.
 
Although Taiwan has been a member of The Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 2013, many participants noted a need to much better understand international regulations. They also expressed a strong desire for more knowledge sharing across the pharmaceutical industry and to have more frequent events with updates and expert discussions. More than half of the attendees are familiar with ISPE, and the strongest proponents have resorted to becoming a member in the USA or another overseas chapter or affiliate. This is currently the only route; for now, until an affiliate has been founded in Taiwan in line with the industry aspirations too!
   
Thomas Terranova
+65 9644 4296
ISPE Singapore Student Chapter Discovery Day: Drugs of Tomorrow
Aston Chia Kai Suan
President,  ISPE Singapore Student Chapter 2018 & 2019
M +65 9139 6323
 

A few Saturdays back (June 22), the ISPE Singapore Student Chapter conducted our Discovery Day programme, a one-day learning camp for students to learn and discuss difference niche topics which will soon make up the 4.0 of the Bio-Pharmaceutical Industry. 

The learning day aligns perfectly with our 2019 agenda: to create a solid platform for students to acquire soft and hard skills that will help them enter and navigate through the Pharmaceutical Industry.

ISPE Indonesia Annual Meeting
Jakarta, 24 - 25   June 2019
Arun C
ISPE Singapore Executive Committee member

The meeting opened with talks on the Indonesian market given by both the governmental level by the minister and by the regulators. As the industry in Indonesia is gearing up for the export market, increasingly, companies are looking to invest on technology and seeking overseas expertise. Also the Pharma industry is actively pursuing Industry 4.0.
 
The talk by the Russian regulator provided insights into CIS countries and could be the next place for exponential growth of Pharma industries looking into the demographic and the population. 
 
On the whole there was lot of participation from the industry both for the conference and the exhibition. Industry is growing over the years and with the current support from the government it is expected to grow at the rate of 8-10%. There was dinner hosted with cultural programs to attract the international crowd.
FEATURED Article

Understanding Biofilm Lifecycle and Remediation Procedures

Biofilm formation in process equipment presents challenges and may lead to serious consequences in GMP related manufacturing.
The presence of a biofilm, which may consist of Gram-positive, Gram-negative bacteria, mold, and bacterial spores on process equipment can affect the safety, identity, strength, quality, or purity of products manufactured with  this equipment. Such effects can lead to adulterated product  which may pose risks to consumers, and lead to regulatory action .
Thanks to our sponsors:

 
 

Events Calendar
Technical Tuesday:
PM Group Office, 1 International Business Park, The Synergy,#02-15/16
Join our regular discussion-based community of practice - NO Powerpoints!
Contact us if you'd like to facilitate a session with a proposed session title and preferred dates.
Pharma 4.0
23 Jul 2019 | 6.00-7.00pm
Cell & Gene Therapy
24 Sep 2019  | 6.00 - 7.00pm

COMING SOON!!  LAST CHANCE TO REGISTER

ISPE @ Singapore Kindness Run in aid of VIVA Foundation for Children with Cancer
3 Aug 2019 | 7am Flag Off
National Stadium
Join us at this organised run as we raise funds for VIVA Foundation for Children with Cancer. Support a worthy cause by running/walking/crawling and/or donating via our giving.sg page. Friends and family are welcome to join!
Reduced group registration fee: 3.5km - S$32 | 10km - S$40 (Only for registrations submitted by ISPE Singapore)
PLUS! ISPE Singapore will contirbute S$20 towards the fee (not applicable to accompanying friends/family).
Run participants will receive the official race pack and group updates in mid-July.
Register here* or 
Sponsor our runners here!
All donations In aid of VIVA Foundation for Children with Cancer ( www.viva.sg)
*registration deadline 18 Jul 2019

NEW! ISPE Singapore Hackathon - Calling Students & Young Professionals*!  
21-22 Aug 2019
Suntec Convention Centre
This year, ISPE Singapore is proud to host the first Hackathon, for students and young professionals (YPs)!
All participants will receive a real-world, industry-relevant case study prior to the beginning of the Hackathon. Industry professionals will judge the presentations.



ISPE Singapore Conference & Exhibition
21-23 Aug 2019
Suntec Convention & Exhibition Centre
Hear from over 60 regional and international speakers across 3 concurrent tracks over 2 days!
Mark your calendars for our annual event, packed with learning, case study experience and informative exhibition.  View this year's packed conference programme here
Limited exhibit spaces & sponsorship available, contact yvonne.leong@ibcasia.com.sg  for details  www.ispesingapore.org
 

Women in Pharma 
Brainstorming Lunch & Talk
22 Aug 2019 | 1pm
Suntec Convention & Exhibition Centre
Entry with a Women in Pharma pin (available at ISPE, CAI & No deviation booths; donations of US$10 / SS$15 and above; all proceeds go to ISPE Foundation). Engage in lively discussion and insights with facilitators drawn from industry leaders. Please contact us if you'd like to facilitate  a discussion table!

NEW! ISPE Singapore Bowling Tournament
3 Sep 2019 | 6.30 - 9.00pm
Westwood Bowl @ Civil Service Club, Bukit Batok Clubhouse
Our first bowling tournament will comprise teams of 5, competing for glory!
Light refreshments and drinks included.
Transport provided from Jurong East departing 6pm
Member: S$ 25 Non-member: S$ 35 Students/YPs/non-bowler: S$ 10

ISPE Singapore Student Chapter
Mark your calendars:
Pheature (A NUSPS & ISPESC Joint Conference) 
21 & 22 Sep 2019
NUS UTown
Skills Workshop series 
July-August (Saturdays)
NUS MD Building
Level Up Season 2 
14 Dec 2019
Temasek Polytechnic
For enquiries contact:  sgispesc@gmail.com


Thirsty Thursday with ISPE!
3 Oct 2019 | 6.30 - 8.30pm
Brotzeit, Westgate Mall, Jurong
Unwind, meet old and make new friends conveniently in Jurong East! Finger food & first round on the house!

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.)
Other Events
Smart Pharma: What Lies Over the Horizon
30 Aug 2019 | 4-7pm
NUS University Hall, Level 2, Lee Kong Chian Wing
(Limited places; entry by donation minimum S$50) 
Organised by NUS Department of Pharmacy, Faculty of Science in aid of Alfred & Lucy Wan Merit Scholarship.
Speakers from HSA, Pfizer & J&J followed by dinner.
For details and registration:  
Events in the Region
ISPE Indonesia Affiliate:
Seminar: Electronic Batch Record (e-BR), Efficiently Enforce GMP and Data Integrity Environment.
23 July 2019
Titan Center, Tangerang, Indonesia
Announcements
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?

A S$50 voucher will be given for each one featured in the next issue. Please write in to ispesingaffiliate@gmail.com
FEATURED Event

ISPE Singapore Conference & Exhibition 2019
21-23 Aug 2019 | Suntec Exhibition Centre, Singapore

Hear from over 60 regional and international speakers across 3 concurrent tracks over 2 days!

Gain unique insights, practical experience and tips from experts and industry peers from Alcon, Amgen, Aurobindo Biologics, AstraZeneca, Biocon Biologics, Dr Reddy's Laboratories, Fosun Pharma, Genentech, Gongwin Biopharm, ICM Pharma, Johnson & Johnson, Lonza Biologics, MSD, Nanogen Phamaceutical Biotechnology, Novartis, Novugen Pharma, Pfizer, Roche, Samsung Biologics, Strides Pharma, Sun Pharma, Takeda Pharmaceuticals, United Laboratories, Wuxi Biologics and many many more!
 
Pre conference half-day workshops: 21 August
  • Hands-On Implementation of Risk-Based Qualification following the New ISPE Baseline Guide
  • Root Cause Analysis and CAPA
Conference tracks:

22 August:
Pharma 4.0
Project Management, Environment, Health & Safety
Aseptic Operations
Data Integrity & GAMP
Manufacturing for Cell & Gene Therapy

23 August:
Quality & Compliance
Lean & Operational Excellence
Cleaning Validation
Technology Transfer

NEW! ISPE Singapore Hackathon - Calling Students & Young Professionals*! 21-22 August
This year, ISPE Singapore is proud to host the first Hackathon, for students and young professionals (YPs)!
All participants will receive a real-world, industry-relevant case study prior to the beginning of the Hackathon. Industry professionals will judge the presentations. Teams will be tasked with developing a solution to their respective challenge and present it to judges on 22 August.
Winners will be announced later that day at Pharmanite.

Women in Pharma Brainstorming Lunch & Talk: 22 August
Entry with a Women in Pharma pin (available at ISPE, CAI & No deviation booths; donations of US$10 / SS$15 and above; all proceeds go to ISPE Foundation)
Engage in lively discussion and insights with facilitators drawn from industry leaders.

1st time! Happy Hour & Young Professionals (YP) Networking: 23 August
23 August 2019, 5.30pm till late, Paulaner Brauhaus
All are welcome to join this informal gathering, after our annual conference winds down.
Whether you're a young or seasoned professional, this is a great opportunity to engage with friends and peers over an ice cold beer. Show your ISPE entry pass and the first drink is on us!

Limited exhibit spaces & sponsorship available, contact  yvonne.leong@ibcasia.com.sg   for details 

View all event details including the latest programme and register at: www.ispesingapore.org

Recent Events
Thirsty Thursday
4 Jul 2019

Held at Brotzeit in Westgate Mall for the first time, the change of venue saw over 40 thirsty attendees. It was great to see more students, YPs and new faces who heard about our gathering from friends in the industry.


Technical Tuesdays
This new series, launched in 2018, has gained a steady with a dozen events held over the year.

Pressure Relief Design - Background
11 Jun 2019
Hygienic Equipment - Mechanical Lifecycle & Care
14 May 2019

Women in Pharma Brainstorming Session
29 May 2019

Over 40 attended this event at Raffles Marina to brainstorm for future events and to share aspirations, knowledge, experiences and concerns for career or for life. Thanks to our facilitators and all for their active participation. We look forward to the next session over lunch on 22 August.

Pharmaceutical Technology Transfer Training Course
6 & 7 May 2019

15 participants attended this official ISPE 2 day practical application course to identify criteria for successful technology transfer.

ISPE Singapore Quiz Night 2019
25 Apr 2019

Congratulations to team KPC  who beat 10 other teams at our annual quiz night!
Thanks to our sponsors 1Supplier, No deviation, PM Group, Repassa & STERIS Group

Your feedback and suggestions are most welcome as we strive to provide you with membership and industry news updates.
Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105