May 2026

Moderna, Inc. announced a publication in the New England Journal of Medicine of the positive Phase 3 study results evaluating mRNA-1010, its vaccine candidate for seasonal influenza. The peer-reviewed article summarizes the safety and efficacy data from Moderna's Phase 3 study (P304) evaluating the relative vaccine efficacy (rVE) of mRNA-1010 against influenza illness compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.

Cipla announced the launch of Ciposcillo®, an advanced oscillometer designed for accurate and precise assessment of respiratory mechanics. The device enables early diagnosis of obstructive airway diseases such as Chronic Obstructive Pulmonary Disease (COPD) and Asthma. Built on US FDA cleared technology and engineered for Indian clinical practice, Ciposcillo® is CDSCO approved and ISO certified.

Metabolic and bariatric surgery offers significantly greater long-term protection against heart attack, stroke and death than widely-used GLP-1 drugs in older adults with obesity and diabetes, according to new real-world analysis study* presented today at the annual meeting of the American Society for Metabolic and Bariatric Surgery (#ASMBS2026).

Saveetha College of Pharmacy (SIMATS), Chennai, jointly in collaboration with the Indian Pharmaceutical Graduates' Association (IPGA) successfully organized a webinar titled “Pharmacy – World of Opportunities” on May 4, 2026. 

INTERESTED IN REGULATORY AFFAIRS LEARN FROM THE EXPERTS JOIN GLOBAL INSTITUTES OF REGULATORY AFFAIRS

Global Institute of Regulatory Affairs provides Industry Oriented Courses in Regulatory Affairs (RA), Quality Assurance & Quality Control (QA/QC) for Life Science Graduates with 100% Placement Assistance in Pharma Sector**
Global Institute of Regulatory Affairs (GIRA) is a change that will help you begin & grow your career in Pharma Industry. GIRA through its industrial expertise offers quality educational programs in the field of Regulatory Affairs and QA/QC. It offers Full time, Part time and Distance Learning courses; this flexibility ensures prior commitments are taken care of and at the same time skills are added to their CVs.

1. Program in  Regulatory Affairs | Offline | Online | eLearning
• Basic Fundamentals of Regulatory Affairs
• Introduction to Regulatory Bodies
• Introduction to Quality Standards for Regulatory Compliance
• Common Technical Documents - CTD (API & Formulation)
• Introduction to eCTD
• ASEAN Common Technical Dossier (ACTD)
• Marketing Authorization Procedures in USA
• Marketing Authorization Procedures/ Channels in Europe
• Marketing Authorization Procedures in India
• Marketing Authorization Procedures in ROW markets
• Maintenance and Annual updates for Marketing authorizations
*Offline Program Suitable for a fresher – involves full day practical classroom training awarded with internship support on completion
*Online Program Suitable for working professionals or new comers looking for weekend learning programs
*eLearning Program Suitable for professionals with high time-constraints allowing flexibility of timing &/OR Duration

2. eCTD | eLearning
• Introduction & Overview of CTD
• CTD Fundamentals (Module 1 - 5)
• eCTD Fundamentals & Details
• Best Practice in Preparing eCTD
• Submission using eCTD Format
• Life Cycle Management for eCTD
• eCTD Software for Compilation & Validation
• Key Point for Successful eCTD Submission
• & 2 Days hands on TRAINING on eCTD Software -Lorenz Docubridge

3. Computer System Validation | eLearning
• Introduction to Validation & CSV
• GAMP 5 & Risk Based Approach
• System Development Life Cycle (SDLC)
• V- Model, GDocP, Validation Master Plan
• Data Collection and Validation Execution Activity
• 21 CFR Part 11, Part 211 & Part 820
• CSV Flowchart, Data Migration
• Data Integrity & ALCOA++
• CSV Templates & Documentation

4. Medical Device Regulatory Affairs | eLearning
• Introduction to Validation & CSV
• GAMP 5 & Risk Based Approach
• System Development Life Cycle (SDLC)
• V- Model, GDocP, Validation Master Plan
• Data Collection and Validation Execution Activity
• 21 CFR Part 11, Part 211 & Part 820
• CSV Flowchart, Data Migration
• Data Integrity & ALCOA++
• CSV Templates & Documentation

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Our programs can be joined by:
- B.Pharm, M.Pharm, and Pharm.D graduates
- B.Sc, M.Sc, and Ph.D. holders in Life Sciences or Chemistry
- BE B-Tech in Biomedical engg, Pharmaceutical engg

The Global Institute of Regulatory Affairs (GIRA), based in Pune and established in 2008, is promoted by Mr. Rajkumar Gupta, the Managing Director of Perfect Pharmaceutical Consultants Pvt Ltd (PPC). GIRA offers specialized training in pharmaceutical regulatory affairs, including postgraduate diplomas and certificate.

GLOBAL INSTITUTES OF REGULATORY AFFAIRS
ISO 9001:2015 | JAS-ANZ Accredited
35 years of Expertise & Trust
Website: - https://www.regulatoryinstitute.com/index.html
Contact: - 91 9595750750 / 020 46970 4472