DrugTheGuide
Conference Jun 22–25, 2027 · Washington, DC

DIA Global Annual Meeting 2027

DIA Global Annual Meeting 2027 — the leading conference for drug development professionals covering regulatory affairs, clinical trials, pharmacovigilance, health economics, data science, and the full drug development lifecycle.

Official site ↗ All events

About DIA Global

The Drug Information Association (DIA) ↗ bridges the full drug development lifecycle — from early discovery through regulatory approval and post-market lifecycle management. With members from over 80 countries, the annual meeting draws 7,000+ attendees and features scientific sessions, regulatory workshops, and dedicated tracks for emerging professionals.

The 2027 meeting in Washington DC places attendees in proximity to FDA headquarters — enabling direct engagement with agency scientists presenting emerging regulatory thinking on real-world evidence, decentralised trials, and biomarker qualification ↗. DIA also serves as a primary platform for advance notice of forthcoming ICH guideline revisions ↗.

2027 Programme Tracks

Regulatory Affairs & Strategy

FDA/EMA submission strategy, NDA/BLA/MAA content requirements, Type A/B/C FDA meetings, Breakthrough Therapy and PRIME designations, Rolling Review.

Clinical Trial Design

Adaptive designs (seamless Phase II/III, group sequential), master protocols, decentralised and hybrid trials, ICH E8/R1 quality-by-design implementation, estimands (ICH E9R1).

Pharmacovigilance & Risk Management

Signal detection in FAERS/EudraVigilance, benefit-risk assessment frameworks, REMS design and performance, periodic safety reporting (PBRER), aggregate reporting.

Real-World Evidence (RWE)

FDA/EMA RWE frameworks, electronic health record data quality, RWD-to-RWE transformation, comparative effectiveness research, RWE in label expansion submissions.

Drug Development in Rare Diseases

Orphan Drug Act and EU Orphan Regulation, natural history studies, single-arm trial evidence packages, Rare Paediatric Disease designation, externally controlled trials.

Data Science & AI in Drug Development

Machine learning for clinical trial enrichment, AI-assisted signal detection in PV, NLP for adverse event extraction, generative AI in regulatory writing, FDA's DSCSA data standards.

Key ICH Guidelines for 2027

GuidelineTopicStatusRelevance
E6/R3 Good Clinical Practice (GCP) Step 4 finalised 2023 Risk-based quality management, decentralised trials
E8/R1 General considerations for clinical studies Step 4 finalised 2021 Quality-by-design, estimand framework, trial efficiency
E9/R1 Statistical principles — estimands Step 4 finalised 2019 Handling of intercurrent events in outcomes analysis
M12 Drug interaction studies Step 4 finalised 2024 In vitro/in vivo DDI, PBPK guidance for DDI prediction
M9 PBPK modelling Step 4 finalised 2021 PBPK for DDI and special populations — regulatory acceptance
E17 Multi-regional clinical trials Step 4 finalised 2017 Global simultaneous development, bridging strategies

Full guideline texts: ICH Guidelines Library ↗

Frequently asked questions

What is DIA (Drug Information Association)?
DIA (Drug Information Association) ↗ is a global non-profit connecting professionals across the full drug development lifecycle. Its 18,000+ members include regulatory scientists, clinical researchers, pharmacovigilance specialists, biostatisticians, health economists, and patient advocates from industry, government agencies (FDA, EMA, PMDA), and academic institutions. DIA publishes the Therapeutic Innovation & Regulatory Science (TIRS) journal ↗.
What regulatory topics are covered at DIA Global?
DIA Global covers: FDA regulatory strategy ↗ and EMA scientific guidelines ↗; IND/NDA/BLA submissions; ICH guidelines ↗ (E6/R3 GCP, E8/R1 study quality, M12 DDI); real-world evidence (RWE) in regulatory submissions; decentralised and adaptive clinical trials; rare disease drug development under Orphan Drug Act ↗; and pharmacovigilance/REMS management.
What is ICH and why does it matter for global drug development?
ICH (International Council for Harmonisation) ↗ develops internationally agreed technical guidelines for pharmaceutical regulation across the US (FDA ↗), EU (EMA ↗), Japan (PMDA ↗), and other regions. Key guidelines: E6/R3 (GCP), E8/R1 (general considerations for clinical studies), M12 (DDI studies), S7A/B (safety pharmacology), Q1A–Q1F (stability), M9 (PBPK). ICH compliance reduces duplicative testing and facilitates simultaneous global submissions.
What is pharmacovigilance and how is it conducted post-approval?
Pharmacovigilance (PV) covers post-approval safety monitoring. In the US, adverse events are reported to FDA FAERS ↗; in the EU to EudraVigilance ↗. Periodic safety reports (PSURs/PBRERs) are submitted at defined intervals. Signal detection uses disproportionality analysis (PRR, ROR). REMS programmes ↗ impose post-market safety requirements for high-risk drugs. EU Risk Management Plans (RMPs) ↗ accompany every new marketing authorisation.
What is real-world evidence (RWE) and can it support regulatory submissions?
Real-world evidence (RWE) derives from real-world data (RWD) — electronic health records, insurance claims, disease registries, wearables — outside traditional RCTs. FDA's RWE programme ↗ (FDAMA Section 505F, FDARA 2022) allows RWE to support label expansions, new indications, and post-market commitments. The EMA's RWE framework ↗ similarly defines standards for regulatory-grade real-world studies. Bias control and data quality validation remain key challenges.