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ICH’s 2003 Vision of a Harmonized Quality Regulatory Approach that Fosters Innovation Continued to Take Form in 2023 and 2024

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024.

The goal is not a new one for ICH but was clearly articulated back in 2003 in an overarching “Quality Vision” calling for the development of “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.”

● PART I: Analytics Guidelines Q14 and Q2(R2)
● PART II: Viral Safety Guideline Q5A(R2)
● PART III: ICH Q1/Q5C Revision and Stability Evaluation
● PART IV: The Role of the New CGT Discussion Group
● PART V: ICH’s M4Q(R2) on the Quality Component of the CTD

Week Ending June 14, 2024: Featuring EMA’s Bouygues on Drug/Device Combination Regulatory Challenges

At the May RAPs Euro Convergence Conference, EMA’s Christelle Bouygues reviewed the challenges that have come to the forefront in implementing Medical Device Regulation (MDR) Article 117 on drug/device combination products and how the Q&A guidance addressing the regulatory expectations has been revised to help address them. She managed to cover a lot of ground in her concise talk on the state of play between regulators and industry on combination product approvals and lifecycle management.

Updates in Brief

FDA Drug Recalls

FDA Warning Letters

EMA NCRs

IPQ’s meeting schedule through October includes:

JULY

AUGUST

SEPTEMBER

OCTOBER

PDA CGT Pharmaceutical Conference
(July 10-11) Tokyo, Japan

CASSS CMC North America
(July 16-17) Gaithersburg, MD

DIA Singapore Annual Meeting
(July 16-17) Singapore

AAPS Summer Scientific Forum
(July 22-25) Kansas City, MO

CASSS CMC Latin America
(Aug 6 and 13) Virtual Only

Bioprocessing Summit
(Aug 19-22) Boston, MA

Duke Margolis Submission Meeting
(Aug 20) Washington, DC

USP Extractables and Leachables
(Aug 26) Virtual Only

ISPE Singapore Conference
(Aug 28-30) Suntec, Singapore

Medtech & Pharma Platform Annual Conference
(Sept 3) Basel, Switzerland

IPAC-RS Inhaled Biologics Workshop
(Sept 4-5) Washington, DC

PDA Manufacturing/Legislation Workshop
(Sept 4-6) Berlin, Germany

PDA/FDA Joint Regulatory Conference
(Sept 9-11) Washington, DC

PDA Sterile Guidance Workshop
(Sept 11-12) Washington, DC

CASSS Mass Spec Symposium
(Sept 11-13) Rockville, MD

CASSS HOS Symposium
(Sept 11-13) Rockville, MD

CASSS CE Pharm
(Sept 15-18) Costa Mesa, CA

CHPA RSQ Conference
(Sept 17-18) Bethesda, MD

ASCGT Policy Summit
(Sept 23-24) Washington, DC

World Medical Innovation Forum
(Sept 23-25) Boston, MA

FDA SBIA Generic Drug Development Workshop
(Sept 24-25) Bethesda, MD

DIA India Annual Meeting
(Sept 24-25) Mumbai, India

PDA Biomanufacturing Conference
(Sept 24-25) Gothenburg, Sweden

IPEC Europe
(Sept 24-25) Vienna, Austria

DIA Latin America Annual Meeting
(Sept 25-26) Brasilia, Brazil

PDA Sustainability Workshop
(Sept 26) Gothenburg, Sweden

TOPRA Annual Symposium
(Sept 30 – Oct 1) Rotterdam, Netherlands

PDA Pharmaceutical Microbiology Conference
(Oct 7-9) Washington, DC

ARM Meeting on the Mesa
(Oct 7-9) Phoenix, AZ

PDA Alternative Microbiological Methods Workshop
(Oct 9-10) Washington, DC

AFDO/RAPS Combination Products Summit
(Oct 9-10) Providence, RI

ISPE Annual Meeting
(Oct 13-16) Orlando, FL

ICDRA
(Oct 14-18) New Delhi, India

PDA Aseptic Manufacturing Excellence Conference
(Oct 15-16) Melbourne, Australia

AAPS 2024 PHarmSCi 360
(Oct 20-23) Salt Lake City, UT

AAM GRx+Biosims
(Oct 21-23) Rockville, MD

CASSS CMC Strategy Forum Europe
(Oct 21-23) Rotterdam, NL

APIC/CEFIC GMP & API Conference
(Oct 23-24) Vienna, Austria

PDA Pre-Filled Syringe and Inj. Devices
(Oct 24-25) Phoenix, AZ

PDA Combination Products Workshop
(Oct 24-25) Phoenix, AZ

DIA/FDA Oligo Conference
(Oct 28-30) Washington, DC

PDA Aseptic Processing Conference
(Oct 29-30) Incheon, Korea

IPQ would like to thank our partners: