From digital transformation efforts, to navigating regulatory inspections post-pandemic, and to BioPharma-specific growth strategies, ISPE continues to provide valuable insights to the industry
Like no other, the bio/pharma industry has been tested and proven its mettle, to create, make and deliver vaccines and treatments to patients, worldwide at speed. Safely. The race to respond forged unprecedented change, from process, procedures, to people.
How will this impact the industry going forward, towards sustainability…
From digital transformation efforts, to navigating regulatory inspections post-pandemic, and to BioPharma-specific growth strategies, ISPE continues to provide valuable insights to the industry.
In Asia, ISPE Singapore Affiliate’s annual conference is well positioned to offer unique and high-level learning and networking opportunities. This year's theme should be no surprise:
Collaboration | Transformation | Digitalization
Delivered as a hybrid event, whether onsite in Singapore or online, expect more quality, breadth and depth of knowledge, insights and expertise alongside in-person and virtual networking options. Understanding ever-pressing demands on time, all Symposium and Conference content is provided on-demand for 6 months post-event.
The 2022 ISPE Singapore Affiliate Conference and Exhibition kicks off with a pre-conference Symposium, delivered online only.
Keynote speakers, leading regulatory agencies and industry colleagues will address ‘Future- Proofing’ Hybrid inspections, International Regulatory Collaboration & Reliance and Stakeholder Collaboration.
Next, ‘Ask The Expert’ Live Q&A are quickfire 15-minute online sessions led by proven knowledge leaders on their respective domain.
i. TRACK A: QUALITY
Addressing the driving force of the pharmaceutical and life science industry–Quality. As manufacturers, suppliers, and services providers have stretched themselves over the pandemic to meet unprecedented demand, the need to provide safe and effective medicines has never been forgotten.
The Keynote address by Dr Ranjana Pathak, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd., India examines QRM through the lens of modernizing current paradigms and moving beyond existing tools and models. Then Jesusa Joyce N.
Cirunay, Director IV, FDA Center for Drug Regulation and Research (CDRR), Philippines, shares how QRM is ensured through the shared responsibility across key stakeholders. 4 additional sessions include 2 panel discussions: ‘GLOBAL QUALITY: The Race to Supply Quality’ & ‘End-to-End & From Development to Manufacturing – Product Quality Life Cycle’.
ii. TRACK B: ATMPs, ASEPTIC PROCESSING & ANNEX 1
A highly requested technical topic, which has always been a challenge to produce medicines free of microorganisms. This afternoon comprises multiple presentations, ending with a discussion on ‘Robust Contamination Control Strategies for ATMPs & Cell-based Therapies’.
Onsite @ Suntec Singapore | Livestreamed online
Hosted onsite at Suntec Singapore, live-streamed directly on the ISPE Singapore Conference & Exhibition website www.ispesingapore.org. This hybrid approach welcomes back in-person delegates who have missed the collaboration of the live experience while offering attendance online.
Get in-depth into topics that are better suited for a deeper dive and audience participation. The first workshop kicks off on Tuesday, August 16th with a virtual session on the “Challenges for GMPs (Good manufacturing practices) for MAbs (Monoclonal Antibodies)”.
Two days later, workshops proper will be held exclusively in-person at Suntec Singapore. Onsite delegates can choose between conference and concurrent workshops. 1 hour in duration, each interactive session will focus on a variety of topics:
Mechanism Modelling, Cleaning Process Optimization for Small Molecule API, Paperless Qualification, Mastering Containment and Regulatory Challenges when Building a HPAPI Facility, Aseptic Compliance, Single-Use System Integrity, Pharm/Biotech 4.0 Road, and Dryers Operation. With a variety of process and high-tech sessions, there’s a workshop applicable to all.
Alongside the last day of the conference, Friday, August 19th, workshops will focus on the most demanding challenges facing today’s manufacturers. Of these, none are as daunting as building a cost-effective sustainable facility. Other sessions include Planning & Executing a Successful Capital Project in Today's Challenging Environment, Quality Risk Management, Accelerating Drug Development for Gene Therapy and Bioprocessing, Powder Handling in Upstream BioManufacturing.
Onsite Exhibition & ‘Power Hour’ Talks
A highlight of moving from online to in-person formats is the buzz of a lively exhibition. A new feature this year is “Power Hour” packed with multiple 15 minute talks at featured booths.
For more details & registration: www.ispesingapore.org