| Event |
Type |
Date |
Focus Areas |
Registration Fee |
| Generic Drugs Forum (GDF) 2025 |
Conference |
4/9/2025 |
ANDA, Bioequivalence, Generic Drug Development |
No |
| Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA |
Conference |
1/28/2025 |
ANDA; BLA; Chemistry, Manufacturing and Controls (CMC); Clinical Trials and Research; Drug Master Files (DMF); IND; Knowledge-aided Assessment and Structured Application (KASA); NDA; New Drug Development; Pharmaceutical Quality; Quality Assessments |
No |
| BsUFA III Regulatory Science Pilot Program: Progress Update |
Webinar |
1/22/2025 |
BLA; Biologics; Biosimilars; International; Regulatory Science |
No |
| FDA Clinical Investigator Training Course (CITC) 2024 |
Conference |
12/10/2024 |
Chemistry Manufacturing and Controls (CMC), Clinical Trials and Research, Digital Health Technologies, Drug Safety, Good Clinical Practice, IND, Inspections, International, New Drug Development, Real World Evidence |
No |
| Clinical Pharmacology Considerations for Novel Therapeutic Modalities |
Webinar |
12/4/2024 |
Antibody Drug Conjugates, Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Oligonucleotide Therapeutics |
No |
| M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance |
Webinar |
11/21/2024 |
ANDA, Bioequivalence, Generic Drug Development, International |
No |
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball |
SBIA Chronicles Podcast |
11/14/2024 |
Artificial Intelligence |
No |
| Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies |
Webinar |
11/12/2024 |
Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Radiolabeled Mass Balance |
No |
| Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation |
Webinar |
11/7/2024 |
ANDA, BLA, Drug Safety, New Drug Development, Risk Management, Risk Evaluation and Mitigation Strategy (REMS) |
No |
| Global IDMP Implementation – Getting Closer to the Goal |
Webinar |
10/16/2024 |
Data Standards, Drug Shortages, Labeling, Electronic Submissions, Pharmacovigilance, Regulatory Submissions |
No |
| ICH M12 Drug-Drug Interaction Studies Final Guidance |
Webinar |
10/9/2024 |
Drug Interaction, New Drug Development, IND |
No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 |
Conference/Workshop |
9/24/2024 |
ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment |
No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 |
Conference/Workshop |
9/12/2024 |
Import/Export, International, Registration and Listing |
No |
| ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA |
Webinar |
9/10/2024 |
ANDA, Generic Drug Development, Regulatory Submissions |
No |
| FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA |
Webinar |
9/4/2024 |
Biologics, Chemistry, Manufacturing, and Controls (CMC), Clinical Trials and Research, Early Product Development, Devices, Digital Health Technologies, Drug Development |
No |
| Environmental Monitoring in Compounding |
Webinar |
7/30/2024 |
Compounding, Environmental Monitoring, Outsourcing Facilities |
No |
| Dataset-JSON Pilot Report and Next Steps |
Webinar |
7/25/2024 |
Data Standards, International, Regulatory Science, Regulatory Submissions |
No |
| Introduction to FDA’s Office of Trade and Global Partnerships |
Webinar |
7/23/2024 |
Combination Products, Drug Supply, International Trade |
No |
| Office of Pharmaceutical Quality (OPQ) Reorganization |
On Demand |
7/16/2024 |
Drug Quality, Emerging Technology, International, Manufacturing, Quality Assessments, Supply Chain |
No |
| Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule |
Webinar |
6/26/2024 |
Advertising, Marketing, Regulatory Submissions |
No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration |
Webinar |
6/18/2024 |
OTC Regulation, User Fees |
No |
| OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites |
Webinar |
6/13/2024 |
Animal Rule, Bioanalysis, Bioavailability, Bioequivalence, Clinical Trials and Research, Good Laboratory Practice |
No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development |
Conference/Workshop |
5/29/2024 |
Advanced Manufacturing, Artificial Intelligence, Biologics, Clinical Trials and Research, Combination Products, Devices, Drug Safety, Drug Supply Chain, Electronic Submissions, New Drug Development |
No |
| Considerations for Drug Products that Contain Nanomaterials |
SBIA Chronicles Podcast |
5/17/2024 |
Nanomaterials |
No |
| Statistical Considerations for Premarketing Risk Assessment |
Webinar |
5/16/2024 |
Clinical Trials and Research, New Drug Development, Integrated Safety Analyses |
No |
| Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval |
Webinar |
5/9/2024 |
ANDA, Generic Drug Development, Meetings, Regulatory Assessments |
No |
| Facilitating Generic Drug Product Development through Product-Specific Guidances |
Webinar |
4/25/2024 |
ANDA, Bioequivalence, Generic Drug Development, Product Specific Guidances |
No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access |
Conference/Workshop |
4/10/2024 |
ANDA, Bioequivalence, Chemistry Manufacturing and Controls (CMC), Controlled Correspondence, Generic Drug Development, Meetings, Product Specific Guidances |
No |
| Expanding Generic Drug Access Through International Engagements |
Webinar |
2/28/2024 |
ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International |
No |
| Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes |
Webinar |
3/7/2024 |
Clinical Trials and Research, New Drug Development, Integrated Safety Analyses |
No |
| Joint US FDA – Health Canada ICH Public Meeting |
Webinar |
2/22/2024 |
International, New Drug Development, Generic Drug Development, Safety, Real Word Evidence, Analytical Validation, Drug Safety, Data Management |
No |
| A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs |
Webinar |
1/18/2024 |
Generic Drug Development, Bioequivalence, ANDA, Meetings |
No |
