Agenda 2021

GPRS Kick-off: Strategies for Investigators Operations: Pandemic Update from the Office of Regulatory Affairs

Panel Discussion: 2020 an 'Unprecedented' year: How USFDA Coped with the Pandemic and What to Expect in 2021

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: ICH Q12

cGMP Inspections Amid COVID-19 Pandemic

The Art of Filing NDA/ANDA and Biologics License Application (BLA) and Post-Approval Changes to the FDA

Growing Momentum of Biosimilars and USFDA Regulations

Panel Discussion: Current Regulatory Requirements in Brazil, Mexico and CARICOM

ANVISA: Regulatory System and Latest Changes

Evolving FDA Quality Assessment for Small Molecule Human Drug Products

UK Regulatory Environment Now and into the Future Including Brexit and Pandemic

Panel Discussion: The power of Remote Personal Interactions - How to Effectively Communicate with Regulators

Biosimilars in Europe: Regulation, Pricing and Policy

Impurity Profiling Overview

Panel Discussion: New Political Landscape – How Will it Impact the Pharmaceutical Regulatory Environment?

GMP Update 2021 and Outlook 2022 – Current Trends and Developments in UK and EU

Drug Device Combinations – Evolving Regulatory Landscape

Indian Pharma Industry and Changing Dynamics of Regulatory Affairs

Clarity of Regulations for Continuous Manufacturing

Panel Discussion: Evolving Regulatory Expectations for Emerging Market Approvals

Regulatory Updates and Amendment of the Pharma Regulations in Japan

Learn the Dos and Don’ts of China NMPA E-Filing

Pharmaceutical Regulatory Affairs in Africa

Regulatory Innovation at Health Canada: Advancing Agile Regulations for Drugs and Devices

Nitrosamine Impurities: ANVISA Regulatory Requirements

Topic_1: NitrosamineTesting: The Regulatory Aspects

This workshop will explore relevant aspects of root cause analysis and risk assessment with respect to potential Nitrosamine contamination in drug substances and drug products. You will hear what you need to know about the required risk assessments for medicinal products containing chemically synthesized APIs and how you can meet the international nitrosamine detection regulatory requirements. Few other learnings are:

  • Introduction: General information and current regulatory updates
  • Gaps in quality control and regulatory oversight that led to the contamination
  • Expectations of regulatory authorities with respect to Nitrosamines
  • Control and risk assessment strategies for early detection and prevention of Nitrosamines
  • Implications for risk assessments
  • Root cause analysis and latest analytical techniques for Nitrosamine identification
  • Latest industry updates and case studies on Nitrosamine impurities

Topic_2: eCTD Preparation and Submission

Global regulatory agencies are committed to implementing the eCTD as standard so regulatory professionals must stay up to date with the latest regulations and trends. During this workshop you will learn:

  • Understand the main components of the eCTD
  • Impact of the eCTD
  • How to comply with the 2020 electronic submissions requirements
  • Guidelines and specifications publishers need to follow and how to incorporate them into your workflow and QC
  • How to apply ICH and regional requirements to your eCTD
  • How to QC and validate an eCTD
  • Tips, tricks, and best practices gathered from industry professionals
  • How to convert from a paper application/dossier to an eCTD