A variation is a change to the terms of a marketing authorization. All the Pharmaceutical producers and importers in EU are required to provide information about variations to the regulatory authorities with their medicines. These variations can be minor with minimal or no impact or can be ‘major’ with significant impact related to the quality, safety and efficacy changes of the medicinal product.
- This webinar provides the guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.
- This WEBINAR will describe the regulatory requirement and procedures and processes for the different types of variations. A structured methodology presented in the WEBINAR shall provide the support to the Pharmaceutical companies and CROs for preparation and submissions of all VARIATIONS as per EU regulatory standards.
- The aim of the webinar is to provide the practical know-how in terms of the most common issues experienced during processing of all types of VARIATIONS that will support applicants in the preparation of the submissions.
If you are involved in any aspect of pharmacovigilance and looking forward to strengthen your pharmacovigilance knowledge, this WEBINAR will help you to increase your knowledge base regarding the techniques and regulatory processes involved in variation submission in Pharmacovigilance in EU.
This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.
- Article 5 procedure: Regulatory and procedural guidance
- Type IA variations and submissions
- Type IB variations and submissions
- Type II variations and submissions
- Variation Submission and Documentation
- Presenting IN change application and submission
- Marketing Authorization Extension application and procedures
- Presenting and handling of GROUPED Variation application
- Checklist for high quality applications submission
- New variations regulation: Regulatory and procedural guidance
- Applications affecting an Active substance Master File (ASMF)
- Work sharing Procedures
- Timelines for submission, review and approval for various categories of variations
- Special considerations
- Orphan drugs and indications
- Designation of EU numbers
- Date of revision of SmPC
- Mockups and specimens
- MRP, National and Centralised products and specific considerations
Sunil has been in the Clinical Research Industry for over 10 years. He held the position of Director of Trainings for a leading Contract Research Organization, HAROM Solutions. His company facilitates the business sector by providing Pharmacovigilance services to Pharmaceutical companies and technical trainings to Medicine, Dental, and Pharmacy, Life Science professionals internationally in the fields of Pharmacovigilance, Clinical Research, and Medical Writing etc. He has been involved in trainings throughout his career particularly in the areas of Pharmacovigilance including ARGUS Safety, Clinical Research and Medical Writing. With over 10 years of experience in the pharmaceutical industry and clinical research organization, Sunil offers his clients the assurance that their drug safety training programs are being conducted by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety trainings in lower cost markets.
Sunil was formerly Manager, Trainings & Operations of Clinical Research and Pharmacovigilance, where he successfully developed and led more than 8 therapeutic area teams and support training and operations functions for the management of Clinical Data and Adverse Event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Sunil is a client certified trainer with expertise in techno-functional training on Oracle Argus Safety 7.0 including Argus activities, User management, Case processing including duplicate check, case book-in, follow up, coding, medical review, reports generating (Expedited, Aggregated, PSUR) and dashboard reports. He ahs proficiency in WHO-DD and MedDRA Dictionary and knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Volume 9A etc
- Pharmacovigilance (including QPPV)
- Clinical Research
- Risk Management
- Drug Safety Assessment Department
- Safety Data Analysis
- Information Technology
- Regulatory Affairs
- Pharmacovigilance consultancy
- Quality and Compliance