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2018 PDA Annual Singapore Conference

Oct 30 - Oct 31, 2018
Singapore, Singapore

New Developments in Bio/Pharmaceutical Manufacturing and Regulation

  • Conference
  • Asia-Pacific
  • Western Hemisphere Events

Overview

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
Email: moir@pda.org

Registration Inquiries

Tel: +1 (301) 656-5900 ext. 115 
Email: registration@pda.org

Agenda

  • 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

    17:00
    Closing Remarks
    Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA


Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Westin Singapore

12 Marina View, Asia Tower 2
Singapore, Singapore

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Conference Registration | October 30-31

Member

By September 30, 2018
$670

After September 30, 2018
$895

Non-member

By September 30, 2018
$895

After September 30, 2018
$1,195


Government/Health Authority/Academic

Member

By September 30, 2018
$300

After September 30, 2018
$400

Non-member*

By September 30, 2018
$300

After September 30, 2018
$400


Student

Member

By September 30, 2018
$110

After September 30, 2018
$150

Non-member*

By September 30, 2018
$110

After September 30, 2018
$150


Young Professional Member

By September 30, 2018
$300

After September 30, 2018
$415


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 registration@pda.org 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 info@pda.org 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.

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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

Sponsors

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Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

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Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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