Despite the devastating impact on human life and the economic and social disruption caused, the COVID-19 pandemic solicited positive outcomes driven by innovation, collaboration and the need to adapt to the changing environment. As we emerge from the calamity, what is now in focus for the supply of medicinal products and the pharmaceutical industry.

• 

  Lisa Bennett (Chair)

  Senior GMP Consultant and Trainer at SeerPharma

  Lisa is an active member of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter. Lisa’s experience comes from a background in Forensic & Analytical Chemistry, accompanied by a Masters in Forensic Science. After beginning her career as an analytical chemist in the petrochemical industry, Lisa moved into roles within the Pharmaceutical Industry where she gained hands on experience in a wide breadth of disciplines such as QC, Stability and Clinical Trials, Supply Chain Logistics, R&D, Aseptic Fill and Finish, QA, Release for supply and auditing. The majority of her time in the industry has been in roles working within the CSL group which manufactures biological products such as vaccines, antivenoms and blood products.

  More information about speaker
• 

  Jenny Burnett

  Head, Manufacturing Quality Branch at Therapeutic Goods Administration

  Jenny Burnett is the current Chair of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) Sub-committee on Strategic Development, representing the Therapeutic Goods Administration as a PIC/S Participating Authority. She is the Assistant Secretary of the Manufacturing Quality Branch (MQB), TGA. MQB assists in the timely supply of therapeutic goods, ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on assessing manufacturers' compliance with Good Manufacturing Practice for medicines, blood, tissues and cellular therapy products and conducting product recalls for all types of therapeutic goods. MQB also has responsibility for the quality requirements for medicinal cannabis, psilocybin and MDMA products.
  
  Jenny has a science background, working as a chemist in both private industry and government laboratories. After a number of years in the TGA Laboratories Branch, and a stint of living overseas for 3 years, she worked in various TGA pre-market assessment areas in medicine regulation before moving to MQB in 2021.

  More information about speaker

By the time we come together for this meeting, the revised requirements of the EU & PIC/S Code of GMP Annex 1 - Manufacture of Sterile Medicinal Products will be in force in Europe and many other regions of the world. What are we hearing from industry and regulatory agencies on the implementation across the globe?

• 

  Richard Denk

  Senior Consultant Aseptic Processing & Containment at Skan AG

  Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

  More information about speaker

• 

  Richard Denk

  Senior Consultant Aseptic Processing & Containment at Skan AG

  Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

  More information about speaker
• 

  Matt Davis

  Senior Inspector at Therapeutic Goods Administration - Australian Government

  Matt Davis is a Senior Inspector – Team Leader, inspection section with the Manufacturing Quality Branch. Matt has been with TGA since 2009.
  Before joining TGA, Matt held positions in the pharmaceutical industry sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA.
  
  His current role at the TGA involves performing both domestic and overseas inspections of manufacturers. Matt is also the Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.

  More information about speaker

Combination Products: Where medical device and drug regulations merge.

• 

  Peter Qiu

  External Advocacy Lead China at Roche Genentech

  Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
  Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
  
  Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

  More information about speaker

• 

  Peter Qiu

  External Advocacy Lead China at Roche Genentech

  Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
  Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
  
  Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

  More information about speaker
• 

  Kerrie Way

  Principal Regulatory Affairs Associate at Vaxxas Pty Ltd

  Kerrie Way is a Principal Regulatory Affairs Associate with Vaxxas, an Australian-based biotechnology company aiming to develop and commercialize a novel needle-free technology for vaccine administration. Kerrie commenced her regulatory affairs career in 2008 at CSL in Melbourne and over the next 9 years was responsible for managing and developing regulatory strategies to support seasonal influenza vaccine registrations in Asian-Pacific and North-South American markets. Before starting at Vaxxas in 2021 she worked as a regulatory consultant offering services to consultancy and pharmaceutical companies, gaining experience with prescription, generic, OTC and botanical products. Kerrie has a B.Sc. (Hons), Ph.D. in Pharmacology from the University of Melbourne, and previously spent more than 10 years as a research scientist within academia in the US and Australia.

  More information about speaker
• 

  Daniel Flewellen

  Senior Consultant / Contracting Services Manager at Seerpharma

  Daniel has 20 years broad pharmaceutical experience across various technological areas (scientific and IT) as a validation and IT compliance specialist. He has experience conducting IT, CSV and DI gap analysis and compliance audits for companies on quality systems and CSV programs. Daniel trains in computer validation (21 CFR Part 11, Annex 11, Data Integrity and GAMP) and assists companies establish IT compliance and computer validation programs.
  
  He regularly gets involved with specific validation projects in clinical, manufacturing and laboratory environments and has expertise in ISO 13485, IEC 62304 and CFR 820 regulations.

  More information about speaker

This presentation will highlight some recent innovations in pharmaceutical modeling and provide an overview of the current regulatory background. An industry perspective of the perceived hurdles for broader implementation and use will be presented, particularly in the context of AI/ML models. Output from key regulatory publications (e.g., FDA FRAME and EMA AI Concept Paper) and fora (PQRI AI/ML workshop, EMA QIG Listen and Learn) will be addressed.

• 

  Ben Stevens

  Director, CMC Policy and Advocacy of GSK

• 

  Ben Stevens

  Director, CMC Policy and Advocacy of GSK

  Ben Stevens is a Director of CMC Policy and Advocacy at GSK and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam where he led the clinical regulatory CMC development of Vutrisiran prefilled syringe in over 30 countries, and the initial US NDA and EU MAA submissions, including one of the earliest Notified Body assessments under the newly implemented EU MDR. Before Ben joined Alnylam, he was a Principal Consultant at PAREXEL and an acting Branch Chief in the Office of New Drug Products (ONDP) at the FDA. At FDA, Ben worked closely with several key policy groups (OPPQ, ORP), partnered with CDRH on matters related to combination product review, and was a government liaison to USP. Before FDA, Ben spent seven years in medicinal chemistry R&D at Pfizer and Merck. Ben has broad regulatory CMC experience in small molecules, peptides, oligonucleotides, botanicals, and combination products. At GSK, Ben leads CMC policy and advocacy for several priority areas, including biologics, CGT, oligonucleotides, and advanced manufacturing. Ben represents GSK in numerous external trade and association working groups (e.g., PhRMA, BIO, IQ, EFPIA, NIIMBL, ISPE, PDA, Biophorum), where he has led and supported policy positions and interactions with global regulators. He received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins Bloomberg School of Public Health, and is a co-author of over 30 publications and patents.

  More information about speaker

• 

  Micheal Schafferius

  Application Specialist for Separation Technologies and Quality at SARTORIUS

  Micheal Schafferius currently holds the position of Application Specialist for Separation Technologies and Quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President.

  More information about speaker

The inability to travel and work in person changed business operations and processes worldwide as we adapted in an attempt to maintain equilibrium. Switching from paper to electronic records, holding virtual meetings, working from home, as we faced these challenges in industry so did our regulatory agencies.
As we emerge from the COVID-19 pandemic and have the opportunity to move way from the innovative ways of working which of these are we keeping and what has been left behind.

Chris Kwang Yong Nam, Samsung Bioepis

• 

  Peter Qiu

  External Advocacy Lead China at Roche Genentech

  Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
  Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
  
  Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

  More information about speaker

ICH Q12 provides the framework to facilitate the management of Post Approval Changes (PACs) in a more predictable and efficient manner across the product life cycle within ICH regions. It aligns with the stated intention of increasing acceptance of science and risk-based approaches manifested in ICH Q8-11, and the understanding of the Pharmaceutical Quality System (PQS), as pre-requisites to enable post approval flexibility.

This presentation will look at the definition of what ICHQ12 calls “Established Conditions” (ECs) and how they can be incorporated to advantage in Submissions. What can then follow at PAC proposal, is that a PACMP (a PAC Management Protocol) can be written, which when implemented significantly streamlines and accelerates changes to enable faster access of medicines to patients. This assumes that the ECs are still met when defining the PAC.

Harmonisation of PAC requirements worldwide, particularly through the implementation ICH Q12, will ensure consistent global regulatory expectations for PACMPs. Change categorization of PACs should be based on science and risk-based approaches, and product/process knowledge and understanding, including full knowledge of what the ECs are.

Agencies can adopt some or all of the tools in ICH Q12 in a sequential fashion (e.g. early adoption of PACMPs) but full adoption per the guideline, without additional requirements will be required to achieve the full intended benefits.

Fundamental to full implementation is the acceptance of the ICH M4Q CTD dossier and the principles for science and risk-based development in ICH Q8-11.

Challenges to implementation can be addressed with robust training and awareness programs; cross-business unit strategy; external cross-industry and Health Authority knowledge sharing in Conferences such as this!

• 

  Bruce Loxley

  Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK

Chris Kwang Yong, Samsung Bioepis (Invited)

• 

  Richard Denk

  Senior Consultant Aseptic Processing & Containment at Skan AG

  Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

  More information about speaker

This presentation offers a comprehensive overview of the latest developments in the cell and gene therapy (C&GT) field, encompassing both global market trends and regulatory updates. With a focus on approved therapies, expected approvals, and ongoing clinical trials, valuable insights into the sector's growth potential and emerging applications are revealed. We delve into the key drivers and challenges influencing C&GT market dynamics, along with exploring technology innovations that aim to enhance process quality and productivity.

Shifting our focus to regulatory trends, we assess the evolving global regulatory environment, including the status of C&GT filings. A particular emphasis is placed on new guidance documents and regulations, with a focus on quality control measures to ensure product safety and efficacy. Lastly, we highlight the significance of developing standards in the C&GT domain, aiming to foster international harmonization and facilitate advancements in this transformative therapeutic area.

• 

  Juliana Gutierrez

  Scientific Affairs Manager at bioMérieux