Certificate Program In Aggregate Report Writing – E-Learning Sessions With Experts & Handson Training
CERTIFICATE PROGRAM IN AGGREGATE REPORT WRITING – e-LEARNING SESSIONS WITH EXPERTS & HANDSON TRAINING
Over the course of the last two years, fundamental changes have been made to the format and structure of aggregate safety reports, triggered by the implementation of the Good Pharmacovigilance Practice measures in the European Union, together with
the updated guidelines on PSURs and RMPs emanating from ICH.
These changes have increased both the complexity of the reports and the input required from non-safety departments, necessitating a new approach to the preparation of aggregate safety reports. This training course focuses on the review and analysis of safety data in the PSUR, the PBRER and DSUR, and presents strategies to ensure effective planning for large PSURs, as well as processes to allow for consistency between safety documents.
Cliniminds has been at the forefront of providing clinical research and pharmacovigilance training and consulting solutions to the life sciences industry for the last several years. We have already trained over 5,500+ professionals. All our programs are internationally accredited.
We are pleased to offer specialized Certificate Program in Aggregate Reporting, consists of hands on training sessions on aggregate report writing.
- Aggregate Reports, Their significance and Types of Reports.
- Preparation and distribution of Periodic Safety Update Reports (PSURs)
- Preparation and distribution of Periodic Benefit- Risk Evaluation Reports (PBRERs)
- Signal detection of Periodic Benefit- Risk Evaluation Reports (PBRERs).
- Preparation and distribution of Periodic Adverse Drug Experience Reports (PADERs)
- Preparation and distribution of Developmental Safety Update Report (DSURs)
Program would help you in developing strong understanding of Aggregate Reporting.
Cliniminds was established in Year 2004 – Tenet Health Edutech Pvt. Ltd., promoted by team of Industry professionals and academia. Its India’s first skill development institution in life sciences domain to receive Pharmaceutical Society of India (PSI), Accreditation Council for Clinical Research Education (ACCRE U.S.).
Following courses we offer; Advanced Post Graduate Diploma in Pharmacovigilance, Data Management & SAS, Advanced Post Graduate Diploma in Pharmacovigilance & Medical Writing, Post Graduate Diploma in Medical & Scientific Content Writing, Advanced Post Graduate Diploma in Pharmacovigilance.
We offer wide range of skill development clinical research, pharmaceutical and healthcare educational programs and training solutions
Our programs sustained by superior copyright content and faculty with global stand point.
We have national Presence – 15 major cities in India, International Centers: USA ; UK, RUSSIA, UAE
Program content is targeted towards all major global markets and address the global regulatory environment. Overseas students are growing from Americas; Europe; Middle East; Africa and other countries.
Key Clients for Training Workshops and Online Training Programs : Oracle, NIH USA; MSD; Fresenius Kabi, Germany; Dabur; Novartis; Quintiles; Ranbaxy; GSK; Bioserve; Max Healthcare; Johnson & Johnson; Panacea Biotec. ...