SBM Management Services, LP’s Post

Exciting highlights from DAY 1 at the Regulatory Affairs Professionals Society (RAPS) / DIA Combination Product 2024 Seminar! 🌐 Dive into the future of drug-device combinations with these actionable insights!   Action Wish List (based on the seminar discussions):   ✔ Ensure more training: Equip stakeholders with comprehensive training on requirements and definitions to prevent misunderstandings and double work.   ✔ Foster improved communication: Strengthen collaboration between stakeholders, with a focus on enhancing communication between NBs and EMA.   ✔ Provide enhanced guidance: Develop clearer processes for product approvals and life-cycle management, complete with well-defined protocols for product changes.   ✔ Embrace a unified category: Transition from categorizing products as pharma or devices to a unified 'medical products' category encompassing all types.   ✔ Streamline approval with scientific advice: Provide scientific advice for DDC device parts to streamline the approval process.   ✔ Establish a single contact point: Simplify the approval process by establishing a single contact point, covering all steps from NBOp to MAA.   ✔ Define roles and responsibilities: Clearly outline roles and responsibilities among stakeholders.   What are your predictions for the future of combination products? Let's continue the conversation – share your insights in the comments below!

🎉 Excited to share that I've completed the Certificate Course in Pharmacovigilance Practical ICSR on LinkedIn! This comprehensive course covered essential topics such as Practical ICSR, Case Validity, MedDRA in ARGUS, Seriousness Assessment, Causality Assessment, and Case Processing in ARGUS. Grateful for the knowledge and looking forward to applying these skills in my professional journey. 🌟 #Pharmacovigilance #ICSR #MedDRA #ARGUS #ProfessionalDevelopment #LifelongLearning

Aurobindo Pharma's Eugia Unit III Sterile manufacturing facility has received a 483 with nine observations, bringing the company back into the regulatory spotlight. The USFDA inspection conducted from Jan 22 to Feb 2, 2024, revealed poor aseptic techniques and inadequate environmental monitoring practices, linked to data integrity concerns. Further enforcement actions are expected based on the seriousness of the observations. A redacted copy of the 483 is attached. At PCGI, we specialize in implementing robust and compliant sterile manufacturing processes and controls to prevent potential 483 observations. Contact us today to learn more. #AurobindoPharma #USFDA #manufacturingcompliance #sterilemanufacturing #483observations #dataintegrityconcerns

Dear All, Thanks for your connect on LinkedIn I would like to introduce myself Sandeep Machhindra Gadge, working in pharmaceutical sector since 2010. I am SME in Validation and Qualification section. As per industry requirement, 1. I will give training (as per USFDA guidelines, EU GMP guidelines, PICS guidelines, WHO guidelines) on Cleaning Validation (MACO calculation, How to select Worst case in cleaning validation, Equipment bracketing, Recovery study, Cleaning agent efficiency study, PDE value, Swab and Rinse technique, Selection of sampling locations, Quantity of Cleaning agent and Purified water, Equipment shared surface area, Finalization of equipment cleaning SOP's etc............ 2. I will assist how to perform cleaning validation activity as per USFDA guidelines, EU GMP guidelines, PICS guidelines, WHO guidelines e. g. Preparation of CV Protocol and their annexures, Preparation of Worst case matrix, MACO Calculation, Preparation of Clean equipment hold time study protocol and report, Preparation of Dirty equipment hold time study protocol and report, Selection of sampling locations, Quantity of Cleaning agent and Purified water, Equipment shared surface area, Equipment bracketing approach, Recovery study, Cleaning agent efficiency study, PDE value, Swab and Rinse technique, etc........ 3. If required, I will perform cleaning validation activity in your organisation with help of your team as per USFDA guidelines, EU GMP guidelines, PICS guidelines, WHO guidelines e. g. Preparation of CV Protocol and their annexures, Preparation of Worst case matrix, MACO Calculation, Preparation of Clean equipment hold time study protocol and report, Preparation of Dirty equipment hold time study protocol and report, Selection of sampling locations, Quantity of Cleaning agent and Purified water, Equipment shared surface area, Equipment bracketing approach, Recovery study, Cleaning agent efficiency study, PDE value, Swab and Rinse technique etc.... If you have to perform cleaning validation activity and any guidence from my side as a Cleaning Validation Consultant then please feel free to contact on +919096272002 sandeep.pharma123@gmail.com #cleaning_validation #validation #consultant #cleaning_validation_consultant #pharma #GMP_consultant #21CFR #Eudralex #MACO #cleaning_agent #Worst_case #PDE_value #CEHT #DEHT #Dose_criteria #10ppm #Health_base_value #process_validation #pharma_consultant #sandeep_gadge

🎓 Today I would like to share about another interesting course, Post-market Surveillance for Batch Management, that I recently completed from Pharmuni. This was the last of the series of exclusive courses on Batch Management.   The comprehensive course covered essential topics such as Pharmacovigilance, stability studies and key manufacturing and quality data insights. I learned how product safety is maintained and efficacy is ensured through continuous monitoring. This reiterated the critical importance of a robust Quality Management System.   Looking forward to bringing this expertise in practice and to keep the learning going! #Pharmacovigilance #QualityManagement #ProfessionalDevelopment

Learn the critical sections of PSMF and understand their vital connection to Pharmacovigilance with Raghda Mohamed at the Drug Safety Symposium 2024. #eminencegroupventures #eminencebusinessmedia #EGV #Dubai #EGVDrugSafety Eminence Business Media - A Eminence Group Company ,Takeda , Vrushali Negandhi , Abhay Dave , Fatema Dhariwala

How are you today? Tell us what you want to hear from us. If you want to stay up-to-date with us, follow our Page. If you want to stay on top of Pharmacovigilance then you definitely need to follow our Page. If you want a rewarding career, follow our Page. If you want to really improve your global safety case processing for speed, accuracy, and on costs you really need to follow our page and RAPTAR. If you want to find out what makes us different, then join us and follow our page. #RAPTAR ⬇ https://lnkd.in/exZFGiw #PharSafer ⬇ https://lnkd.in/eimySG2 🙂

I am absolutely thrilled to have completed the Pharmacovigilance and Technovigilance course! I have gained so much new knowledge in this area that is both fascinating and useful to apply in my professional practice and daily life.

Live discussion November 8 on how Biotechs outsource safety operations while getting control of the safety system and real-time data access. You’ll hear: 🔸 Outsourcing PV best practices to gain oversight and reduce compliance risk 🔸 Key safety considerations as companies advance from clinical trials to commercialization 🔸 How to accelerate implementation (8 weeks) and eliminate maintenance with a modern solution 🔸 How Biotechs build a business case for owning a safety solution Register now. https://bit.ly/3MiCexi #biotechs #pharmacovigilance #safety

⚡ Are you attending #GPVRMS24 in a few weeks and still haven't booked your room? ACT NOW! Room block closes at the end of the day (or until rooms run out)⚡ 🚨 Still thinking about registering? What are you waiting for? C'mon on down and join us! But act quickly to reserve your room 😉 🚨 🖥 diaglobal.org/GPVRMS24 #pharmacovigilance #clinicalsafety #drugsafety