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The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Orphan Drugs and Combination Products in Latin America The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating…
08-May-2025 - 09-May-2025

This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan. Learning Objectives: Regulatory guidelines for Clinical Data Management Best practices for data collection CDISC/CDASH/STDM standards Responsibilities of personnel Case report form criteria Maintaining confidentiality of data Data storage and transferability Data preparation and quality assurance for accuracy Data monitoring plan criteria Data systems validation Adverse event reporting and coding criteria What to expect on a monitoring visit Troubleshooting and resolution of deviations from plan Who will Benefit: Study Investigators Da…
22-May-2025 - 23-May-2025

7, Holiday Inn Brussels Airport, an IHG Hotel, Holidaystraat, VB, 1831, Belgium

BD & L Training Course is a 2-day course that will equip you with the essential skills and knowledge needed to navigate the complex landscape of licensing, partnerships, and negotiations. At our course, you will learn from industry experts who have a deep understanding of the valuation approaches, risk assessment methodologies, and deal structuring techniques that are currently shaping the pharma-biotech world. We have carefully designed the agenda to cover all the crucial topics, ensuring that you leave with a comprehensive understanding of the deal-making process.
BD & L Training Course

This two day interactive seminar will focus on: Complaint Management Medical Device Reporting (MDR) EU Vigilance Reporting Product Recalls This course will provide practical guidance and real life examples that will help you develop and/or optimize your company’s post market surveillance system. Learning Objectives : Key goal of this course is to understand: Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls) Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls) Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recall…