39 Presentations Featuring 18+ Hours of Content
No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest regulatory presentations and packaged them into the ISPE Best of Pharma Series. Access the most premier presentations offering compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations.
Sneak Peek of What to Expect
Watch this short clip from Carmelo Rosa, PsyD presenting Inspections During a Pandemic An Update on Alternate Approaches and Cross-Agency Communication for a glimpse of the kind of content you’ll engage with in the ISPE Best of Pharma Series: Regulatory.
Presentations in this Package
Application of ICH Q12, Established Conditions, and a Product Life Cycle Management Document to the Analytical Aspects of the 2019 FDA Q12 Pilot Program
Speaker:
- Michael Cohen, PhD, Research Fellow – Global CMC, Pfizer
Duration: 32 min
Authorities - Between Keeping Pace with Innovation and Maintaining Regulatory Oversight
Speakers:
- Mark Birse, Vice President, Technical, Regulatory Consulting Services, Parexel
- Bernd Boedecker, Ex-EU GMP Inspector - Germany, GMP Freelance Consultant
Duration: 22 min
Advance Notice to FDA: Ensuring Manufacture and Supply of Life-Saving Medicines
Speaker:
- Jeannie David, Senior Program Management Officer, Drug Shortages Staff, CDER/FDA
Duration: 20 min
Case Study in Aseptic Process Operations
Speaker:
- José Meléndez, Consumer Safety Officer, FDA/ORA
Duration: 45 min
Control Strategies and Risk Mitigation
Speaker:
- David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA
Duration: 30 min
Distant Assessments - An Option After Covid-19?
Speaker:
- Jacques Morenas, ANSM Mark Birse, Parexel
Duration: 21 min
Drug Security, Integrity, and Recalls
Speaker:
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
Duration: 32 min
Drug Shortages
Speaker:
- Emily Thakur, CDR, Team Leader, Drug Shortages Staff, CDER/FDA
Duration: 20 min
Drug Shortages Initiative in ISPE - Introduction to the Regulatory Panel Discussion
Speaker:
- Diane Hustead, Merck
Duration: 12 min
Enabling End to End Continuous Manufacturing: FDA Perspective
Speaker:
- Sharmista Chatterjee, PhD, Division Director, OPMA, OPQ/CDER
Duration: 28 min
FDA Input on COVID-19: Learnings and Consequences
Speaker:
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
Duration: 29 min
FDA Perspective on Data Integrity
Speaker:
- Seneca Toms, MS, RAC, Biotechnology Drug Specialist Investigator, ORA/FDA
Duration: 21 min
FDA Perspective on GMPs for Cell & Gene Therapies
Speaker:
- Ekaterina Allen, PhD, RAC, Regulatory Project Manager and CMC Facilities Reviewer, FDA/CBER
Duration: 29 min
FDA Perspective on the Implementation of ICH Q12
Speaker:
- Terrance Ocheltree, PhD, President, PharmTree Consultants
Duration: 6 min
GMP Inspection Reliance: Experience to Date and Future Expectations & Swissmedic GMP Guidance Implementation
Speaker:
- Anne Hayes, HPRA Christian Schaerer, Swissmedic
Duration: 22 min
ICH Q12 and Beyond: The Journey Towards Regulatory Convergence in Product Life Cycle Management
Speaker:
- Nina Cauchon, PhD, Director, Regulatory Affairs – CMC, Amgen Inc.
Duration: 28 min
ICH Q13 Guidance – Continuous Manufacturing of Drug Substance and Drug Product
Speaker:
- Rapti Madurawe, PhD, Division Director, FDA/CDER/OPQ/OPPQ
Duration: 15 min
Inspections During a Pandemic: An Update on Alternate Approaches and Cross-Agency Communication
Speaker:
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
Duration: 13 min
ISPE Global Strategy After COVID 19 - What Is Important?
Speaker:
- Thomas Hartman - President and CEO of ISPE
Duration: 29 min
Lessons Learned: Responding to COVID-19
Speaker:
- Sarah McMullen, PhD, Deputy Director, India Office, FDA
Duration: 24 min
Novo Nordisk Foundation Focus on COVID
Speaker:
- Niels Peder Nielsen, Deputy CEO of the Novo Nordisk Foundation (NNF)
Duration: 21 min
Out-of-Specifications (OOS)
Speaker:
- Jila Breeze, SVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries
Duration: 24 min
Practical Implementation of Medical Devices, Apps and Digitisation - Company Perspective
Speaker:
- María Jesús Salido, SocialDiabetes, S.L.
Duration: 18 min
Quality & Compliance (ICH Q10/Q12) and Risk Mitigation Live Question & Answer/Discussion
Speakers:
- Fran Zipp, President & CEO, Lachman Consultant Services
- David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA
- Christiane Hamacher, PhD, CEO and Managing Director, Biocon Biologics
Duration: 56 min
Regulatory Expectations and Trends in Aseptic Processing: Review of Recent Findings
Speaker:
- Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER
Duration: 21 min
Regulatory Flexibility during COVID-19
Speaker:
- David Churchward, Deputy Unit Manager, Inspectorate Strategy, and Innovation (Expert GMP Inspector), MHRA
Duration: 15 min
Regulatory Panel Discussion: Distant Assessment on GMP and Inspection Reliance
Speakers:
- Søren Thuesen Pedersen, Moderator
- Alice Redmond, Moderator
- Mark Birse, Parexel
- Domenico di Giorgio, AIFA
- Anne Hayes, HPRA
- Christian Schaerer, Swissmedic
- David Churchward, MHRA
- Jacques Morenas, ANSM
- Monika Mayr, EMA
- Vladislav Shestakov, Russia
- Bernd Boedecker, ISPE for Germany
- Bob Tribe, ISPE Regulatory Advisor
Duration: 61 min
Regulatory Panel Discussion: Drug Shortages and COVID-19
Speakers:
- Diane Hustead, Moderator
- Jean-François, Moderator
- Domenico di Giorgio, AIFA
- Jacques Morenas, ANSM
- Simeon Gill, MHRA
- Carmelo Rosa, FDA
- Manuel Ibarra Lorente, AEMPS
- Stephanie Croft, mWHO
Duration: 57 min
Regulatory Panel Discussion: How Can Pharma 4.0 Help to Manage COVID Crisis?
Speakers:
- Christian Woelbeling, Moderator
- Teresa Minero, Moderator
- Johanna Gouws, WHO
- Carmelo Rosa, FDA
- David Churchward, MHRA
- Vladimir Orlov, EAEU
- Susanne Keitel, EDQM
- Igor Falkovski, Russia
- Manuel Ibarra Lorente, AEMPS
Duration: 81 min
Regulatory Trends
Speakers:
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
- José Meléndez, Consumer Safety Officer, FDA/ORA
Duration: 35 min
Regulatory Trends on Cleaning Validation – Case Studies
Speaker:
José Meléndez, Consumer Safety Officer, FDA/ORADuration: 22 min
Supply Chain and Cleaning Validation Q&A Discussion
Speakers:
- Fran Zipp, President & CEO, Lachman Consultant Services
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
- Jila Breeze, SVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries
- David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA
- Antonio Crincoli, PE, Senior Director, Head Upjohn Global Engineering, Pfizer Inc.
- Sarah McMullen, PhD, Deputy Director, India Office, FDA
- José Meléndez, Consumer Safety Officer, FDA/ORA
- Ranjana Pathak, DHA, President, Global Quality, Medical Affairs and Pharmacovigilance, Cipla
Duration: 54 min
Supply Chain and OOS Q&A Discussion
Speakers:
- Fran Zipp, President & CEO, Lachman Consultant Services
- Jila Breeze, SVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries
- Emily Thakur, CDR, Team Leader, Drug Shortages Staff, CDER/FDA
- José Meléndez, Consumer Safety Officer, FDA/ORA
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
- Johnny Mikell, Head of Global Quality, Lupin
Duration: 44 min
The Role of Advanced Manufacturing in Addressing Current Industry & Patient Needs
Speaker:
- Stelios Tsinontides, PhD, Director, Office of Pharmaceutical Manufacturing Assessment, FDA
Duration: 21 min
Update on CDER’s Quality Management Maturity Program
Speaker:
- Jennifer Maguire, PhD, Acting Director, Office of Quality Surveillance, CDER/FDA
Duration: 24 min
Update on Collaboration Efforts with India Regulators
Speaker:
- Letitia Robinson, PhD, Country Director, India Office, FDA/ORA
Duration: 11 min
Update on PIC`S Annex 2 for ATMPs
Speakers:
- Richard Denk, SKAN AG
- Francesco Cicirello, TGA, Head of PIC`s Annex 2
Duration: 29 min
Updates on Recent Combination Product Initiatives at the US FDA Part 1
Speakers:
- Melissa Burns, Senior Program Manager, Office of Combination Products, CDER/FDA
- Steven Hertz, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER, FDA
Duration: 21 min
Updates on Recent Combination Product Initiatives at the US FDA Part 2
Speakers:
- Melissa Burns, Senior Program Manager, Office of Combination Products, CDER/FDA
- Steven Hertz, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER, FDA
Duration: 21 min
Virtual Inspections: Navigating the New Paradigm
Speaker:
- Monica M. Commerford, PhD, Manager of Regulatory Affairs, Brammer Bio