Casss.org

  1. Home
  2. Casss.org

Singapore’s New Cell, Tissue and Gene Therapy Products …

WEBSingapore’s New Cell, Tissue and Gene Therapy Products Regulations. Home / Papers and Presentations / Resource. In This Section. Papers and Presentations. Share this article: …

Actived: 2 days ago

URL: https://www.casss.org/papers-and-presentations/resource/speaker-presentation-singapore-s-new-cell-tissue-and-gene-therapy-products-regulations

Wassim Nashabeh Announced as CASSS Hancock Award Winner …

WEBNashabeh was announced as the 2024 honoree during CASSS’ Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health …

Category:  Health Go Health

Microbial Challenge In-use Studies

WEBSpeaker Presentation Leiske Seagen Inc. Zamiri Genentech 2022 Microbial Challenge In-use Studies - Industry efforts to harmonize strategies in collaboration with Health …

Category:  Health Go Health

CMC Strategies for Expedited Program Development

WEBMay 2022 20(5) BioProcess International 17 therapy; if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and if

Category:  Health Go Health

World Mental Health Day

WEBOctober 10 is World Mental Health Day. The World Health Organization (WHO) recognizes this day each year to raise awareness about mental health all over the world and to …

Category:  Health Go Health

Project ORBIS: Opportunities and Challenges from the CMC …

WEBParticipation by both Biologic and Radiopharmaceutical Drug Directorate (BRDD; biologics) and Therapeutic Product Directorate (TPD; small molecules) Products are either new …

Category:  Health Go Health

Emergence and Advancement of Technologies: Regulatory

WEBRegulation of Gene and Cell Therapy Products in Canada (cont’d) Cell and Gene Therapeutic Products. Regulated as Biologics, in Schedule D (Biologic Drugs) of the …

Category:  Health Go Health

CMC Strategy Forum Japan

WEBWith the support from the Pharmaceuticals and Medical Devices Agency (PMDA, Japan), as well as the Japan Pharmaceutical Manufacturers Association (JPMA), this CMC Forum …

Category:  Medical Go Health

Health Canada Implementation of ICH Q12: CMC Changes

WEBIntroduction of the Level III – Immediate Notification reporting category will allow the notification of changes in a timely manner of the changes that have been …

Category:  Health Go Health

CMC Regulatory Expectations for Biological Therapeutic …

WEB7 General CMC considerations in IND development o For initiation of a Phase I study, product safety is the first and utmost consideration (e.g., viral clearance, …

Category:  Health Go Health

Lessons Learned: Compatibility and In-Use Stability Studies

WEBA potency assay might be the only viable approach to assess protein concentration and drug product degradation for dilute products. other methods may not be sufficiently …

Category:  Health Go Health

Phase Appropriate GMP Expectations for Analytical Methods …

WEBPhase Appropriate Expectations for Analytical Methods and Process Validation for Expedited Programs: A Regulatory Perspective Megan Powdrill, Ph.D –Biologist/Evaluator

Category:  Health Go Health

Roundtable 35: Microbial Challenge In-use Studies and

WEBRoundtable 35: Microbial Challenge In-use Studies and Requirements Facilitator: Camellia Zamiri, Genentech, a Member of the Roche Group, South San Francisco, CA, USA …

Category:  Health Go Health

Health Canada: Update on Regulatory Activities & Priorities

WEBRegulatory Priorities Examining our review system to determine the best approaches to: • better respond to healthcare system needs, and • improve timely access to effective …

Category:  Health Go Health

January 24, 2023

WEBMicrosoft Word - WCBP 2023 Final Program. 08:00 - 08:30. CASSS Welcome and the 11th Annual William Hancock Award. Presented by: Julia Edwards, Genentech, a Member of …

Category:  Health Go Health

Table 3: Host Cell Proteins Identification, Strategies

WEBTable 3: Host Cell Proteins – Identification, Strategies, Successes and Challenges Facilitators – Dawn Kelly, Merck & Co., Inc. Mark Paciga, Merck & Co., Inc. Scope: Host …

Category:  Health Go Health

Top Categories

 › Appendicitis

 › Headaches

 › Gout

 › Women's Health

 › Thyroid

 › Sleep

 › Skin

 › Sexual Health

 › Senior Health

 › Pregnancy

 › Oral Health

 › Neurology

 › Migraine

 › Mental Health

 › Men's Health

 › Menopause

 › Medications

 › Lung Conditions

 › Infectious Disease

 › HIV/AIDS

Popular Searched

 › Dr wasem khan mercy health

 › Population health and aco

 › Brooke county health department wv

 › School of public health yale

 › A mental health provider in maryland must release records to a client upon written request

 › Can i still get united health care in prairie du chien wi

 › Health care professionals indemnity insurance

 › Www.evds.health.gov.za login

 › Healthy thigh size for women

 › Cottage health goleta physicians

Recently Searched

 › Most important stakeholder in health care

 › Healthpartners healthy benefits program

 › Pre deployment health assessment army login

 › Spectrum health lab 35 michigan

 › Health information management entry level salary

 › Buffalo community healthcare center reviews

 › Louisville metro public health department

 › Meridian mental health sylva nc

 › State of oregon health insurance exchange

 › Population health vs individual care