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MEDICAL SAFETY WRITER TRAINING

Training by ACI- Pharmacovigilance Training Specialist

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Academy of Clinical Intelligence ( ACI ) 17A Sector 17, Chandigarh, Chandigarh, India 160017

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This training program covers all the technical and regulatory aspects of Medical Safety Writer Job and the participant gets hands on experience on writing and review of various regulatory safety reports.

CLINICAL DEVELOPMENT PHASE

• DSURs
• IND Annual Reports
• Clinical SAE narratives

MARKETING AUTHORISATION PHASE

• Summary of Clinical Safety (CTD Module)
• Clinical Overviews (overview of safety)
• EU RMPs
• US REMS
• Integrated Summary of Safety

POST-MARKETING PHASE

• EU PSURs/PBRERs
• US PADERS/PAERs
• 120-Day Safety Update Reports
• Clinical Overview Addenda (ACO)
• Ad hoc reports including safety reviews & summaries
• RSI variations & documentations

AT THE END OF THE TRAINING YOU WILL BE ABLE TO

Author safety reports independently for medicinal products including collection organization, analysis, presentation the data (line listings and summary tabulations) and drafting of safety medical evaluations by means of standard operating procedures.

Lead safety writing projects to develop new writing processes for regulatory reports in alignment with international regulations

Author safety reports independently for medicinal products including collection organization, analysis, presentation the data (line listings and summary tabulations) and drafting of safety medical evaluations by means of standard operating procedures.

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ACI is a globally recognized, Pharmacovigilance Training Management Company primarily focused on creating qualified pharmacovigilance professionals through our high quality and Industry recognized trainings. ACI has been instituted to cater to the growing demand for ‘skilled professionals', essentially addressing the gaps that exists between what an educational institution teaches and what an organization requires.

Since its foundation in 2013, ACI is a leading Professional Training company located in Chandigarh, specializes in Pharmacovigilance training. ACI has been dedicated to create Pharmacovigilance Professionals through technical training program from a fresher to corporate level.

Our programs are customized as per the global regulatory and industry standards with a progressive approach to ensure that the Pharmacovigilance trainings are imparted with focus on creating Pharmacovigilance professionals.

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Medical Writing