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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Annual Singapore Conference

New Developments in Bio/Pharmaceutical Manufacturing and Regulation
Oct 30 - Oct 31, 2018 |
Oct 31, 2018 |
Westin Singapore | Singapore, Singapore
  • Conference
  • Asia-Pacific
  • Western Hemisphere Events
Exhibition: October 30-31
Post-Workshop: November 1
Courses: November 1-2
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The 2018 PDA Annual Singapore Conference will present a truly global outlook on the developments in pharmaceutical regulations in Asia, Europe, and the United States, and efforts by international organizations such as PIC/S to harmonize these regulations. Regulators from each of these key regions and China will participate, discussing their experiences and sharing their perspectives on key regulatory trends.

Hot topics to be addressed include:

  • Quality culture and its implications, focusing on what is important to measure, how it can be effectively measured, and how it can be improved.
  • Data integrity, including the analysis of case studies, noncompliance reports, and warning letters,  that will lead to best practice advice on how to identify,  remedy,  and avoid data integrity problems.
  • Big data and manufacturing intelligence, exploring how to make effective use of manufacturing data to improve processes and ensure consistent product quality.
  • Trends in manufacturing, exploring how various innovative technologies can help the industry to better serve patients.

Hear what the experts have to say about the latest trends in manufacturing concepts and technologies and get all of your pressing questions answered during the Q&A portions of the sessions.

Plan to spend time in the exhibition area, where service providers and equipment and machine manufacturers will showcase the latest products and solutions to help your company improve quality and efficiency.

Extend your learning by attending the post-conference workshop on artificial intelligence (AI) and training courses on cleaning and disinfection and quality culture.

Conference and Exhibition/Sponsorship Inquiries

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: +1 (301) 656-5900 ext. 132

Registration Inquiries

Tel: +1 (301) 656-5900 ext. 115 

Tuesday, 30-October

7:00 – 17:00
Registration Open

8:15 – 10:00
P1: Global Developments in Regulations
Moderator: Andiyanto Sutandar, Technical Director, HGP Asia Pte. Ltd.

This session will highlight some of the activities of PIC/S, the new Annex 1, regulatory issues, and challenges of good distribution practice in Asia.

8:15 – 8:30
Welcome and Opening Remarks from Conference Chair                                           
Andiyanto Sutandar, Technical Director, HGP Asia Pte. Ltd.

8:30 – 9:00
Update on the Activities of the Pharmaceutical Inspection Cooperation Scheme (PIC/S)
Boon Meow Hoe, Deputy Director (Overseas Audit)/Senior GMP Auditor, Health Sciences Authority (Singapore)

9:00 – 9:10
Questions and Answers/Discussion

9:10 – 9:40
Cold Chain Integrity: A Case Study from India
Greg Basset, Executive Director, Quality Amgen Inc.
Anand Garg, Senior Director – Head India Supply Chain, Dr. Reddy's Laboratories

9:40 – 10:00
Questions and Answers/Discussion

10:00 – 10:30
Refreshment Break in Exhibit Area

10:30 – 12:00
P2: Regulatory Update
Moderator: Dinesh Khokal, PhD, Director, External Affairs, Corporate Quality, JAPAC and Intercontinental, Amgen Inc.

This session will give an overview of new regulations from countries who were not members of the ICH process in the past. Any globally active company needs knowledge of these regulations to be successful in these countries.

10:30 – 11:15
Regulatory News from Brazil, China, India, Russia, and Asia Pacific
Hongyang Li, Head of APAC MS&T, Solids, Novartis Technical Operations, Novartis

11:15 – 11:45
Regulations of Pharmaceuticals in South East Asia: How to Maintain Quality Standards
Sherry Wang Xueying, USP

11:45 – 12:00
Questions and Answers/Discussion

12:00 – 13:00
Networking Luncheon

13:00 – 15:00
P3: Quality Culture, Part 1
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

The pharmaceutical industry is globally active. In different countries, there are differences in understanding how and what is needed to achieve quality for the manufacturing of pharmaceuticals. In this session, several aspects of what quality culture in a pharmaceutical environment means will be addressed, including: why it is important, measuring it, quality systems, ways to drive quality improvements, and human error reduction.

13:00 – 13:30
What Is Important to Achieve a Quality Culture and How to Keep It
Cylia Chen, MS, External Affairs Senior Manager, Amgen Inc.
13:30 – 14:00
How to Measure and What Drives Quality Improvements
Rifky Adythia, Business Process Excellence Manager, Boehringer Ingelheim

14:00 – 14:30
Quality Culture: An Achievable Goal
Martin Wisher, Senior Regulatory Consultant, Merck

14:30 – 15:00
Quality Culture Assessment at Baxter
Sateesh Yelisetti, Head, External Contract Manufacturing, QA, Baxter Healthcare (Asia) Pte Ltd

15:00 – 15:30
Refreshment Break in Exhibit Area

15:30 – 17:00
P4: Quality Culture, Part 2
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

This session is a continuation of the preceding session and will end with a panel discussion addressing the quality culture situation in Asia Pacific and what steps need to be taken to get to an international acceptable level.

15:30 – 17:30
Developing Quality Culture in Emerging Countries
Michelle Peake, Senior General Manager, PT Kalbio Global Medika

16:00 – 16:30
Behavioural GMP: Human Error Reduction
David Spaulding, Training Manager, SeerPharma

16:30 – 17:30
Panel Discussion on Quality Culture in Asia Pacific

Wednesday, 31-October

7:30 – 17:30
Registration Open

8:30 – 10:00 a.m.
P5: Big Data/Manufacturing Intelligence
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

This session will address how to extract data from SAB reports in the new era of tech and how to make sense of data spread across many systems for large volumes of text-heavy documents. Identifying information hidden in those documents is challenging. Natural Language Processing (NLP) provides a range of “keys” to help unlock the rich information in those documents. Data scientists using open source code and platforms can apply NLP to pull context from words and then use Machine Learning to make predictions. The result is insight and intelligence not previously available. This discussion provides an overview of how this can be accomplished in the biopharmaceutical industry. In addition, the activities of PDA in this field will be presented and discussed.

8:30 – 9:00
Unlocking Hidden Information in Quality Data using Data Science
Dan Weese, MS, Executive Director, Quality Data Sciences, Amgen Inc.

9:00 – 9:30
PDA Manufacturing Intelligence Task Force Update
Aaron R. Goerke, PhD, Director, Head of Manufacturing Science and Technology, Roche

9:30 – 9:45
Panel Discussion

9:45 – 10:30
P6: Data Integrity
Moderator: Sateesh Yelisetti, Head, External Contract Manufacturing, QA, Baxter Healthcare (Asia) Pte Ltd

Data integrity plays a key role. Many problems have been seen and regulatory inspectors have described many problems. With increasing automation and big data handling procedures this issue will continue to be very important. This presentation will share observations in companies on three continents and will highlight the different approaches.

9:45 – 10:15
Data Integrity: Case Studies from Three Continents
Martin Wisher, Senior Regulatory Consultant, Merck

10:15 – 10:30
Questions and Answers/Discussion

10:30 – 11:00
Refreshment Break in Exhibit Area

11:00 – 12:15
P7: Trends in Manufacturing: Facility and Process
Moderator: Wallace I. Torres, PhD, Executive Director, Site Quality Head – Drug Substance, Amgen Inc.

The pharmaceutical industry faces a situation which is characterized by cost pressures and a need to satisfy an increasing number of regulations. The following two sessions will address approaches which help to meet these demands. Starting from new concepts of facilities to implementing novel approaches of manufacturing and test methods.

11:00 – 11:30
Manufacturing Facilities: The Modular and Flexible Approach
Dennis Powers, Director of Sales Engineering, G-CON Manufacturing

11:30 – 12:00
Current Debates and Challenges in Disinfectant Coupon Testing
Jim Polarine Jr., MA, Senior Technical Service Manager, STERIS Corporation

12:00 – 12:15
Panel Discussion

12:15 – 13:15
Networking Luncheon

13:15 – 15:00
P8: Trends in Manufacturing: Continuous Manufacturing and New Technologies
Moderator: David Spaulding, Training Manager, SeerPharma

Typically, pharmaceutical processes are done stepwise with intermediates after the unit operation. Recently, approaches are taken to do the processing continuously, avoiding intermediates and connecting the unit operations. This needs a good understanding of the unit operation and a very good control. This session gives insights into the concept of continuous manufacturing and describes technical and regulatory implications. Two elements of such processes are analyzed in more detail: chromatography and contaminant detection in biologics production.

13:15 – 14:00
Continuous Manufacturing: Technical and Regulatory aspects
Sudhakar Nagaraj, Senior Manager - Pharma and Regulatory Consultant, South and South East Asia, Pall Corporation

14:00 – 14:45
Disruptive Technologies for Contaminant Detection in Biologics Production
Martin Wisher, Senior Regulatory Consultant, Merck

14:45 – 15:00
Questions and Answers/Discussion

15:00 – 15:30
Refreshment Break in Exhibit Area

15:30 – 17:00
P9: Trends in Manufacturing: Important Elements of the Future: Patient Convenience and Patient Specific Drugs
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

This session begins with a presentation describing how to improve patient compliance by making it easy for the patient to apply the drug using devices, like pens. In the second presentation, attendees will hear about cell therapy approaches which make the drug patient-specific, and like this, reducing adverse effects and being more effective than currently existing drugs. Though there are many activities ongoing only few drugs are available yet, that will change soon.

15:30 – 16:00
Ensuring Successful Drug Delivery System
Hendri Harmoko, PhD, Senior Manager, Technical Services, BD Singapore

16:00 – 16:30
Immuno-Oncology Cell Therapy
Gary Khoo, Head of Process Sciences and Technology, Tessa Therapeutics

16:30 – 17:00
Questions and Answers/Discussion

Closing Remarks
Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

Conference Registration | October 30-31


By September 30, 2018

After September 30, 2018


By September 30, 2018

After September 30, 2018

Government/Health Authority/Academic


By September 30, 2018

After September 30, 2018


By September 30, 2018

After September 30, 2018



By September 30, 2018

After September 30, 2018


By September 30, 2018

After September 30, 2018

Young Professional Member

By September 30, 2018

After September 30, 2018

All prices in US dollars.

* For this member type or discounted rate, online registration is not available and must be faxed in.

You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by October 12, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before October 12, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING: Tape recordings are prohibited at all PDA Conferences.


Westin Singapore
12 Marina View
Asia Square Tower 2
Singapore, 018961, Singapore

Rate: S$340.00++ per room per night (Single)
*Room rate includes breakfast and high speed internet access and is exclusive of the 10% service charge and prevailing government taxes, currently at 7% goods & services tax (GST).

Hotel Accommodations

To make reservations at the Westin Singapore, please call the Hotel at +65-6922-688 and reference PDA Conference to receive the PDA group rate. Check in time is 15:00, and check out time is 12:00.


Perfectly located within the vicinity of Marina Bay and walking distance from Chinatown and Marina Bay Sands, the Westin Singapore is rated among some of the renowned 5-star hotels in Singapore, providing you a soothing, contemporary escape amidst the bustling city. From our signature Heavenly® Beds to our Level 35 Infinity Pool, the hotel offers world-class facilities and services that inspire you to be at your best.

Hotel Parking

Guests traveling by car may park at Asia Square Tower 1 or 2 (carpark charges apply). Self and valet parking are available as well. Valet Parking Charges: SGD20 net (excluding parking charges)

Mass Rapid Transit (MRT)

The MRT offers fast, convenient transportation to the financial district, downtown, and historic Chinatown. The hotel is walking distance to three MRT stations:

  • 10 minutes walk: Raffles Place Interchange Station (NS26 & EW14) connected to the North-South and East-West lines.
  • 10 minutes walk: Marina Bay Interchange Station (NS27 & CE2) connected to the North-South and Circle lines.
  • 3 to 5 minutes walk: Downtown Station (DT17) connected to Downtown line.
  • If you are interested in exhibiting at or sponsoring this event, please contact Molly Moir at