Dear Colleagues, Looking forward to seeing you in Singapore, Andiyanto Sutandar, Technical Director, HGP Asia Pte. Ltd.

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1 2018 PDA Annual Singapore Conference New Developments in Bio/Pharmaceutical Manufacturing and Regulation October 30-31, 2018 Westin Singapore Singapore, Singapore Dear Colleagues, 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. Looking forward to seeing you in Singapore, Conference Chair The Program Planning Committee Sudhir Goudar, Executive Director, Senior Compliance Officer, Group Compliance and Audit, Novartis Dinesh Khokal, PhD, Director, External Affairs, Corporate Quality, JAPAC and Intercontinental, Amgen Inc. David Spaulding, Training Manager, SeerPharma Sateesh Yelisetti, Head, External Contract Manufacturing, QA, Baxter Healthcare (Asia) Pte Ltd Georg Roessling, PhD, Senior Consultant, Business Development, PDA 1

2 Tuesday, 30-October 7:00 17:00 Registration Open 2018 PDA Annual Singapore Conference New Developments in Bio/Pharmaceutical Manufacturing and Regulation October 30-31, 2018 Westin Singapore Singapore, Singapore 8:15 10:00 P1: Global Developments in Regulations Moderator: 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 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) (Invited) 9:00 9:10 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 10:00 10:30 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 12:00 13:00 Networking Luncheon 13:00 15:00 P3: Quality Culture, Part 1 2

3 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 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 15:30 17:30 P4: Quality Culture, Part 2 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 16:00 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 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 3

4 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 10:15 10:30 10:30 11:00 11:00 12:15 P7: Trends in Manufacturing: Facility and Process Moderator: Wallace I. Torres, MBA, Executive Director QA, Site Head Drub 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 13:00 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 14:45 15:00 4

5 15:00 15:30 15:30 17:00 P9: Trends in Manufacturing: Important Elements of the Future: Patient Convenience and Patient Specific Drugs 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 17:00 Closing Remarks Georg Roessling, PhD, Senior Consultant, Business Development, PDA 5