Catalogue / Health & Social Care / Pharmaceutical

Pharmaceutical

Title	Publisher
An Introduction to Clinical Trial Preparation and Design (CT04)	Zenosis
An Introduction to Clinical Trials and Drug Development (CT07)	Zenosis
An Introduction to Drug Safety and Pharmacovigilance (PV03)	Zenosis
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01)	Zenosis
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01)	Zenosis
Assuring Data Integrity in the Manufacture of Medicinal Products	Zenosis
Clinical protocol design (CT04B)	Zenosis
Clinical Research Teamwork (CT03B)	Zenosis
Clinical study design (CT04F)	Zenosis
Clinical Trial Documentation (CT03C)	Zenosis
Clinical trial endpoints (CT04d)	Zenosis
Clinical trial investigator's GCP responsibilities (CT03E)	Zenosis
Clinical trial monitor's GCP responsibilities (CT03G)	Zenosis
Clinical Trial Monitoring: Site Evaluation and Set-up (CT06)	Zenosis
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure (CT08)	Zenosis
Clinical Trial Preparation (CT04C)	Zenosis
Clinical Trial Safety Reporting Requirements in the EU and USA (CT14)	Zenosis
Clinical trial sponsor's GCP responsibilities (CT03D)	Zenosis
Clinical trials in drug development (CT04A)	Zenosis
Commissioning and Installation Qualification (VAL03)	Zenosis
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ICT01)	Zenosis
Computer Systems Validation, Part 1: Planning (VAL06)	Zenosis
Computer Systems Validation, Part 2: Implementation (VAL07)	Zenosis
Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02)	Zenosis
Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA (SAM03)	Zenosis
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (GMP07)	Zenosis
Data capture (CT04G)	Zenosis
Documentation (GMP01)	Zenosis
Electronic Common Technical Document (eCTD) (SUB05)	Zenosis
Equipment Cleaning Validation (VAL05)	Zenosis
Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01)	Zenosis
Essentials of Monoclonal Antibodies (ESS02)	Zenosis
GMP – what and why	Zenosis
Good Clinical Laboratory Practice (GLP03)	Zenosis
Good Clinical Practice Inspections and Audits (CT09)	Zenosis
Good Documentation Practice (GMP02)	Zenosis
Good Laboratory Practice	Zenosis
Good Manufacturing Practice for the Warehouse (GMP04)	Zenosis
Good Manufacturing Practice in Cleaning and Sanitation (GMP03)	Zenosis
Good Manufacturing Practice in Packaging Medicinal Products (GMP06)	Zenosis
Good Manufacturing Practice in Processing Medicinal Products (GMP05)	Zenosis
Good Pharmacoepidemiology Practice (PV07)	Zenosis
Good Practices (GxP) in Drug Development and Manufacturing (GXP01)	Zenosis
Good Quality Control Laboratory Practice (GLP02)	Zenosis
How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12)	Zenosis
How to Gain Approval to Conduct Clinical Trials in Europe (CT01)	Zenosis
How to Gain Approval to Market a Generic Drug in the USA (SUB13)	Zenosis
How to Gain Authorisation for Clinical Research under the EU Clinical Trials Regulation (CT11)	Zenosis
Hygiene cleaning and sanitation (GMP01c)	Zenosis
ICH Good Clinical Practice (CT03)	Zenosis
ICH, Harmonisation and Principles of Good Clinical Practice (CT03A)	Zenosis
Informed Consent in Clinical Trials (CT03F)	Zenosis
Introduction to Validation (VAL01)	Zenosis
Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA (SAM01)	Zenosis
Marketing of Prescription Drugs in the USA - Interactions with Healthcare Professionals (SAM04)	Zenosis
Medical Devices - An Introduction to the Regulation of Medical Devices (MD01)	Zenosis
Operational and Performance Qualification (VAL04)	Zenosis
Orphan Drug Designation in the USA and Europe (SUB01)	Zenosis
Preparing Submissions in the Common Technical Document (CTD) Format (SUB04)	Zenosis
Principles of GMP (GMP01b)	Zenosis
Registration of Medicinal Products Based on Monoclonal Antibodies (SUB12)	Zenosis
Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA (SAM02)	Zenosis
Risk Management Planning for Medicinal Products (PV05)	Zenosis
Safety Reporting in Clinical Trials (CT13)	Zenosis
Signal Detection and Management in Pharmacovigilance (PV04)	Zenosis
Statistical elements (CT04E)	Zenosis
The 505(b)(2) Application for Marketing Approval in the USA	Zenosis
The Biologics License Application (BLA) for Marketing Approval in the USA (SUB15)	Zenosis
The Decentralised Procedure (DCP) (SUB11)	Zenosis
The European Centralised Procedure (CP) (SUB02)	Zenosis
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials (CT10)	Zenosis
The Mutual Recognition Procedure (MRP) (SUB03)	Zenosis
The New Drug Application (NDA) for Marketing Approval in the USA (SUB09)	Zenosis
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA (SUB14)	Zenosis
Urgent Safety Restrictions (PV06)	Zenosis
Validation Plans and Documentation (VAL02)	Zenosis
Variations to Marketing Authorisations in Europe (SUB06)	Zenosis