Webinar Duration: 3 hours
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Amer Alghabban
Pharmacovigilance or drug safety -is a broad term that describes the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.
This means that at the time of a medicine’s authorisation, it has been tested in a relatively small number of selected patients for a limited length of time. After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances. It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.
Why should you Attend: This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).
The course incorporates inspections at sponsor and contract research organisation (CROs) sites, as well as at the investigator site. The course will also cover common inspectional findings, current inspection finding trends, and inspection critical topics/focus trends. A review of the differences between methodologies of FDA inspections and EMA is also included.
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Areas Covered in the Session:
– Pharmacovigilance overview: Brief history
– The need to have pharmacovigilance process
– Aims of Pharmacovigilance
– Pharmacovigilance for generics versus new medicinal products
– What are drug risks?
– Measures to identify drug risks
– Pharmacovigilance system: Minimum required elements
– The Risk Management System
– Pharmacovigilance concepts’ definitions
– Responsibility of Sponsor/Marketing Authorization Holders’ employees
– Undertesting the legal frameworks and reading between the lines which is paramount to enable better understanding and consequently better
Who Will Benefit: This introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance such as:
– Clinical Research/Trials’ Leaders, Data Managers, Clinical Trials Physicians
– Clinical Research Coordinators, Clinical Investigators, Study Nurses
– Clinical Research Associates, Pharmacovigilance/Drug safety Professionals
– QA GCP Auditors, Drugmakers, Devicemakers, Executive suite, Regulatory Affairs, QA GVP Auditors, Legal counsel, TMF Managers, Consultants
Amer Alghabban is currently the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies to achieve compliance with GCP, GVP, GCLP and GLP. Amer has over 27 years’ experience in the pharmaceutical industry. He has been an invited speaker at over 110 international congresses. Mr. Alghabban has published reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA. As part of his current role as QA Expert, he is serving as GxP QA adviser for Allecra Therapeutics SAS and has served as VP of GxP Quality Assurance, Compliance at Karyopharm Therapeutics Inc. and similarly as the Senior QA representatives of Biotech companies in Switzerland and the U.K. Prior to GCTP, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland.
His other previous positions included Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.