Agenda 2022


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On Demand

Global regulatory landscape - Fostering innovation, convergence and harmonization

"Transitioning EUA to full approvals: Regulatory perspectives and lessons learnt in the COVID-19 pandemic"

Key consideration for use of RWE & RWD in driving regulatory decision making

"The regulatory landscape in 2022 – Clinical Trials Design - Decentralized, diversity and digital implications"

"What to keep in mind for cGMP Inspection and communication on your cGMP regulatory practices"

Key Do’s & Don’ts for ANDA – Authoring, filing and submiting new regulations

"Insights on FDA safety information and adverse event reporting program: Fail-safe for reducing recalls"

"FDA regulatory strategy for promoting innovation - Regulatory flexibility and agility the key driver for scientific & digital Innovation"

"Pan American regulatory landscape panel: Building a holistic strategy to bring efficiencies to regulatory systems"

"Mitigating US drug & medical devices shortage - Regulatory requirements with FDA and industry perspectives"

Faster, flexible & future proof pharmaceutical strategy- Evolving regulatory framework in Europe

IDMP Focus: Preparedness and global implementation roadmap

Managing regulatory system with digital, agile, data-driven future

"The future of drug - Device combination product regulation: Differentiating MDR V/s IVDR "

Additional – FDA Drug-Device Classification Highlights

ICH Q12 – CMC regulatory spotlight for biologics & biosimilars

UK outlook of the regulatory roadmap by MHRA - Post Brexit

Key developments in CTR & CTIS: Understanding Clinical Trials Regulation EU No 536/2014 (CTR) with its key component the Clinical Trial Information System (CTIS)

Empowering regulatory intelligence for enabling efficiency in regulatory decision making

Overview on regional pharmaceutical supply chain regulations: National competent authorities & industry panel

Indian regulatory updates

Japan regulatory update: PMDA

"China NMPA (CFDA) key updates: Factors to consider in the submission that will impact approval time, downstream sales, and post-market compliance"

"ASEAN Regulatory Roundtable: Innovation, collaboration & regional integration of ASEAN pharma regulations"

API & Excipient quality risk assessment with Nitrosamine in GMP expectations

"Regulatory requirements for marketing & post marketing authorisation in EAEU/ CIS region"

Middle East regulatory landscape

African regulatory landscape - Pharma regulation in Africa: Current state and opportunities

Health Canada - Forward Regulatory Plan 2021-2023

WORKSHOP 1 - Building towards Global Identification of Medicinal Products (IDMP) Implementation

"WORKSHOP 2.A - Regulatory and Medical Writing – Key Success Mantras about Filing, Documenting, Authoring"

"WORKSHOP 2.B - Training on Insights on API Testing, Nitrosamine and other excipient Testing"