ISPE Best of Pharma Series: Regulatory

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.

ISPE Best of Pharma Series: Regulatory Rates

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

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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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Case Study in Aseptic Process Operations

Speaker: 

  • José Meléndez, Consumer Safety Officer, FDA/ORA
Duration: 45 min

Partner Solutions

Control Strategies and Risk Mitigation

Speaker: 

  • David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA
Duration: 30 min

Partner Solutions

Distant Assessments - An Option After Covid-19?

Speaker: 

  • Jacques Morenas, ANSM Mark Birse, Parexel
Duration: 21 min

Partner Solutions

Drug Security, Integrity, and Recalls

Speaker: 

  • Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
Duration: 32 min

Partner Solutions

Drug Shortages

Speaker: 

  • Emily Thakur, CDR, Team Leader, Drug Shortages Staff, CDER/FDA
Duration: 20 min

Partner Solutions

Drug Shortages Initiative in ISPE - Introduction to the Regulatory Panel Discussion

Speaker: 

  • Diane Hustead, Merck
Duration: 12 min

Partner Solutions

Enabling End to End Continuous Manufacturing: FDA Perspective

Speaker: 

  • Sharmista Chatterjee, PhD, Division Director, OPMA, OPQ/CDER
Duration: 28 min

Partner Solutions

FDA Input on COVID-19: Learnings and Consequences

Speaker: 

  • Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC
Duration: 29 min

Partner Solutions

FDA Perspective on Data Integrity

Speaker: 

  • Seneca Toms, MS, RAC, Biotechnology Drug Specialist Investigator, ORA/FDA
Duration: 21 min

Partner Solutions

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

Partner Solutions

FDA Perspective on the Implementation of ICH Q12

Speaker: 

  • Terrance Ocheltree, PhD, President, PharmTree Consultants
Duration: 6 min

Partner Solutions

GMP Inspection Reliance: Experience to Date and Future Expectations & Swissmedic GMP Guidance Implementation

Speaker: 

  • Anne Hayes, HPRA Christian Schaerer, Swissmedic
Duration: 22 min

Partner Solutions

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

Partner Solutions

ICH Q13 Guidance – Continuous Manufacturing of Drug Substance and Drug Product

Speaker: 

  • Rapti Madurawe, PhD, Division Director, FDA/CDER/OPQ/OPPQ
Duration: 15 min

Partner Solutions

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

Partner Solutions

ISPE Global Strategy After COVID 19 - What Is Important?

Speaker: 

  • Thomas Hartman - President and CEO of ISPE
Duration: 29 min

Partner Solutions

Lessons Learned: Responding to COVID-19

Speaker: 

  • Sarah McMullen, PhD, Deputy Director, India Office, FDA
Duration: 24 min

Partner Solutions

Novo Nordisk Foundation Focus on COVID

Speaker: 

  • Niels Peder Nielsen, Deputy CEO of the Novo Nordisk Foundation (NNF)
Duration: 21 min

Partner Solutions

Out-of-Specifications (OOS)

Speaker: 

  • Jila Breeze, SVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries
Duration: 24 min

Partner Solutions

Practical Implementation of Medical Devices, Apps and Digitisation - Company Perspective

Speaker: 

  • María Jesús Salido, SocialDiabetes, S.L.
Duration: 18 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Regulatory Flexibility during COVID-19

Speaker: 

  • David Churchward, Deputy Unit Manager, Inspectorate Strategy, and Innovation (Expert GMP Inspector), MHRA
Duration: 15 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Regulatory Trends on Cleaning Validation – Case Studies

Speaker: 

José Meléndez, Consumer Safety Officer, FDA/ORA
Duration: 22 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Update on CDER’s Quality Management Maturity Program

Speaker: 

  • Jennifer Maguire, PhD, Acting Director, Office of Quality Surveillance, CDER/FDA
Duration: 24 min

Partner Solutions

Update on Collaboration Efforts with India Regulators

Speaker: 

  • Letitia Robinson, PhD, Country Director, India Office, FDA/ORA
Duration: 11 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Virtual Inspections: Navigating the New Paradigm

Speaker: 

  • Monica M. Commerford, PhD, Manager of Regulatory Affairs, Brammer Bio
Duration: 24 min

ISPE Best of Pharma Series: Regulatory Rates

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

Buy Now

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