Prispevki

• How can regulatory outsourcing optimise your RA resource allocation? (28/11/2025)
• Why are ICH GCP principles essential for creating compliant clinical documentation? (27/11/2025)
• How do PV requirements influence the role of the QPPV under GVP? (25/11/2025)
• Why do underreporting trends remain one of the core challenges in veterinary pharmacovigilance? (24/11/2025)
• How can a regulatory strategy improve the efficiency of your approval pathway? (21/11/2025)
• How can you distinguish a veterinary adverse event from normal pharmacological effects? (19/11/2025)
• Why your company can’t wait: ePI as a catalyst for digital health (18/11/2025)
• Which pharmacovigilance vendor criteria truly predict long-term reliability? (18/11/2025)
• What steps should you take to maintain medical accuracy in data-driven writing? (17/11/2025)
• What are common pitfalls when preparing “CTD module” submissions, and how can understanding the “CTD format” and “CTD modules” help avoid them? (14/11/2025)
• How can we implement effective signal detection in veterinary pharmacovigilance using spontaneous reporting systems? (12/11/2025)
• How can you document findings from an audit trail review for regulatory success? (11/11/2025)
• How does a pharmacovigilance manager differ from a drug safety officer? (10/11/2025)
• Understanding clinical study protocols, clinical study reports, and investigator brochures in drug development (07/11/2025)
• What are the regulatory requirements for QPPV in veterinary pharmacovigilance? (06/11/2025)
• How can an effective pharmacovigilance risk management plan enhance early detection of safety risks? (05/11/2025)
• Which qualifications and experience are required to pursue QP certification in the EU? (04/11/2025)
• Billev Pharma East at CPHI Frankfurt 2025 (03/11/2025)
• Pharmaceutical bulletin – new safety alerts for medicines (30/10/2025)
• How advanced are the analytics and AI-features in modern pharmacovigilance software solutions? (30/10/2025)
• How do regulatory frameworks (such as EU GMP Annex 16) shape the batch release requirements? (29/10/2025)
• What is the veterinary adverse reporting guideline and how should It be followed? (29/10/2025)
• Billev Pharma East at the Global Pharmaceutical Regulatory Affairs Summit 2025 in Berlin (24/10/2025)
• How can teams prepare effectively for pharmaceutical auditing? (23/10/2025)
• What are the most common medical writing mistakes and how can you avoid them? (22/10/2025)
• How can you start and grow a pharmacovigilance career in today’s regulatory landscape? (21/10/2025)
• Veterinary pharmacovigilance outsourcing: boost compliance and efficiency (20/10/2025)
• Pharmacovigilance audit readiness: how to prepare for regulatory inspections (17/10/2025)
• Our Colleague Jana Brajdih Čendak publishes in Therapeutic Innovation & Regulatory Science - strengthening drug safety through enhanced pharmacovigilance (17/10/2025)
• Billev Pharma East Ltd’s participation at TOPRA Symposium 2025 in Berlin (17/10/2025)
• Medical storytelling for diverse audiences: writing that connects HCPs, regulators, and patients (17/10/2025)
• Quality assurance roles and responsibilities: QP vs. QA manager explained (15/10/2025)
• What are the main methods used in veterinary risk management? (10/10/2025)
• What are common challenges in medical publishing and how to overcome them? (10/10/2025)
• What are the best GMP solutions: Custom or Off-the-Shelf? (09/10/2025)
• How can you tell your company needs pharmacovigilance outsourcing? (08/10/2025)
• How can artificial intelligence medical device solutions support technical file documentation and compliance? (03/10/2025)
• What happens after an adverse drug reaction report Is filed? (02/10/2025)
• How do safety reporting requirements impact adverse event reporting? (01/10/2025)
• How do EU requirements shape qualified person qualification for outsourced QP release? (30/09/2025)
• How can external GMP consultants support compliance with Eudralex Volume 4 while meeting company needs? (25/09/2025)
• What methods ensure efficient medical device technical file data collection? (24/09/2025)
• How does the importance of veterinary pharmacovigilance protect animal health outcomes? (23/09/2025)
• What is patient safety and why pharmacovigilance matters for regulatory compliance? (23/09/2025)
• What are the core requirements of MDR Article 117 for combination products? (18/09/2025)
• How Is medical writing AI transforming drafting and review processes? (18/09/2025)
• How does data integrity in pharma underpin effective GMP documentation practices? (15/09/2025)
• Why must lifecycle management be part of medical device technical file preparation? (11/09/2025)
• What 6 qualified person requirements highlight global regulatory differences? (10/09/2025)
• When is the right time to outsource to a medical writing service? (08/09/2025)
• What are the most common medical device technical file mistakes to avoid? (05/09/2025)
• 7 key elements: what should a CAPA Plan include to address audit findings and audit observations? (04/09/2025)
• What are the 5 common challenges faced in regulatory medical writing and medical writing services? (03/09/2025)
• Implementing ePI across digital channels for better e-labelling access  (29/08/2025)
• Why is GMP training for employees essential – and what should it cover? (25/08/2025)
• What to consider for your upcoming EPI implementation / E-Labelling implementation in line with EMA labelling guidelines (21/08/2025)
• GMP compliance meaning: 6 most common pitfalls – and how to prevent them (18/08/2025)
• Choosing the right EPI solution? Start with the PLM Portal (14/08/2025)
• Pharmaceutical bulletin – new safety alerts for medicines (12/08/2025)
• How does an outsourced QP service ensure compliance and risk mitigation? (12/08/2025)
• What is structured product labeling and why is it essential for high-quality EPI? (08/08/2025)
• What key services are typically offered by GMP consulting services? (04/08/2025)
• How does e-labelling help us understand what is electronic product information? (01/08/2025)
• GMP checklist guide: how to prepare for successful GMP audits step by step (29/07/2025)
• What steps must a QP follow to ensure a proper QP release and uphold the GMP certificate? (24/07/2025)
• Why are GMP guidelines and GMP requirements essential for compliance? (23/07/2025)
• What Is ISO 13485 certification and why choose a full-service package? (21/07/2025)
• ISO 13485 checklist for small manufacturers: from scratch to certification (16/07/2025)
• Top 7 tips for the ISO 13485 auditor evaluating supplier performance (07/07/2025)
• Billev Pharma East Ltd's participation at MedTech Summit 2025 in Berlin (04/07/2025)
• ISO 13485 internal audit: how to identify gaps and drive continuous improvement (13/06/2025)
• Which standard should you choose: ISO 9001 and 13485 for your business needs? (12/06/2025)
• How to assess ISO 13485 compliance: conducting an effective gap analysis (11/06/2025)
• ISO 13485: what is it and what are the key requirements? (10/06/2025)
• Why is MDR Annex II crucial for medical device technical file approval? (09/06/2025)
• Which sections are mandatory in a medical device technical file template? (04/06/2025)
• New medical devices act (ZMedPri-1) – Alignment with EU MDR/IVDR (03/06/2025)
• How can you optimize technical file medical device timelines for faster market access? (27/05/2025)
• Is your medical device technical file aligned with ISO 14971 risk management requirements? (19/05/2025)
• Why is technical file medical device consulting essential for navigating MDR requirements? (15/05/2025)
• Billev Pharma East at the Slovenian Pharmaceutical Society Symposium: Driving Pharmaceutical Innovation at the 50th SFD Congress 2025 (14/05/2025)
• Medical device technical file requirements for CE marking (06/05/2025)
• VNRA, VRA (06/05/2025)
• Pharmaceutical Bulletin – New Safety Alerts for Medicines (28/04/2025)
• Billev Pharma East Achieves ISO 13485:2016 Certification – A Landmark Achievement in Slovenia (14/04/2025)
• Billev Pharma East Reflects on Key Takeaways from GMP PharmaCongress 2025 (10/04/2025)
• ESMP: A Solution for Medicine Shortages (04/04/2025)
• Future Governance Of Medical Technologies In Europe (24/03/2025)
• The European Health Data Space (EHDS) Regulation Enters into Force, Marking the Beginning of the Transition Period (17/03/2025)
• Insights from the RAC25 Conference: Revision of the EU pharmaceutical legislation; digital transformation (SPOR, PMS, eAF) and electronic product information (07/03/2025)
• Signal Detection: How to never miss a PRAC safety signal recommendation (05/03/2025)
• Live from Amsterdam: Billev Pharma East Kicks Off at the RAC25! (28/02/2025)
• The Future of Regulatory Affairs is Here – and We’re Leading the Conversation! (25/02/2025)
• Enhancing Pharmaceutical Manufacturing: FDA Considerations for Complying with 21 CFR 211.110 (21/02/2025)
• ICH Guideline M13A: A Unified Approach to Bioequivalence (07/02/2025)
• Pharmacovigilance Bulletin – New Safety Alerts for Medicines (31/01/2025)
• Important news for submitting variations – updated eAF form (17/01/2025)
• Caring Together in 2025 (08/01/2025)
• A Call for Reform: Addressing Challenges in EU MDR and EU IVDR (20/12/2024)
• EMA Highlights Supply Chain Traceability to Support Qualified Persons (QPs) (11/12/2024)
• Successful Collaboration with TOPRA: Key Insights Shared (05/12/2024)
• New EU Health Technology Assessment Regulation to Transform Market Access for Oncology Drugs, ATMPs, and Medical Devices (03/12/2024)
• Gradual roll out of EUDAMED (28/11/2024)
• The MDCG’s Role in Medical Devices Regulations in the EU (15/11/2024)
• Pharmacovigilance Bulletin - A New Resource for Healthcare Professionals (30/10/2024)
• Billev Pharma East Ltd. attends TOPRA 2024 Symposium in Rotterdam (22/10/2024)
• Join Suzana Šalinger’s Expert Course on Veterinary Marketing Authorisation Variation in the EU (11/10/2024)
• EMA Updates Q&A Document on Combination Products (08/10/2024)
• New EMA Guidelines on Environmental Risk Assessment for Medicinal Products Now in Effect (23/09/2024)
• Newly Issued ICH Guideline M13A on Bioequivalence (16/09/2024)
• Control of Nitrosamine Impurities in Human Drugs - FDA Guidance for the Pharmaceutical Industry (12/09/2024)
• Implementation of Pharmacovigilance Changes Following the Windsor Framework Agreement (09/09/2024)
• Antimicrobial Resistance in Veterinary Medicine (03/09/2024)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024 (20/08/2024)
• The first revision of the ERA Guideline by EMA (12/08/2024)
• Second edition of the Product Lifecycle Management Insights newsletter released by EMA (07/08/2024)
• EMA and EU Commission Strengthen Measures to Prevent and Mitigate Medicine Shortages (26/07/2024)
• Pharmacovigilance Bulletin (03/07/2024)
• Public Consultation on Variations Classification Guideline (24/06/2024)
• Launch of New CTIS Public Portal (20/06/2024)
• Billev Pharma East’s expansion into Medical Devices with Focus on Post-Market Surveillance (17/06/2024)
• Implementing Article 17 of EU Medical Device Regulation: A Step Towards Harmonized Practices (12/06/2024)
• ICH E2D(R1) Guideline on Post-Approval Safety Data: Public Consultation Open until June 22nd 2024 (06/06/2024)
• New Veterinary Medicines Regulations in UK came to force on May 17th 2024 (28/05/2024)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024 (21/05/2024)
• Ukraine’s Regulatory Reforms from May 2024 (16/05/2024)
• APIC CEFIC issued revised version of Best practices guide for managing suppliers of API manufacturers (11/04/2024)
• EMA: Update of Q&A for MAH on Nitrosamine Impurities (25/03/2024)
• EudraVigilance – EVWEB User Manual UPDATE (14/03/2024)
• Artificial intelligence in medical device legislation (08/03/2024)
• The role of a PRRC under the EU MDR & IVDR (28/02/2024)
• Swissmedic: Updated requirements for dealing with potential nitrosamine impurities in medicinal products (27/02/2024)
• EMA/HMA/EC: First Union Critical Medicines list (23/02/2024)
• Billev Pharma East a member of SBC (05/02/2024)
• Billev Pharma East will attend EUCROF24 (05/02/2024)
• Billev Pharma East is pleased to announce active participation at DIA, RSIDM in Bethesda, USA (01/02/2024)
• Update of EMA Q&A document on Combination Products (22/01/2024)
• Updated MDCG Guidance document MDCG 2019-07 Rev.1 released (10/01/2024)
• About Joint Action on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices (09/01/2024)
• New MDCG Guidelines Regarding Importers and Distributors of Medical Devices (08/01/2024)
• EU and MHRA extend GMP and GDP Certificates (14/12/2023)
• Navigating the Path to Medical Device Certification (05/12/2023)
• Navigating Biosimilar Medicines Policies in EU Healthcare (30/11/2023)
• EMA: Update of Q&A on Nitrosamine Impurities (23/11/2023)
• Interpretation of Annex 1 - SwissMedic Publishes Q&A Document (21/11/2023)
• Introducing the EMA's EU Solidarity Mechanism (26/10/2023)
• EMA published Guideline on Quality, Safety, and Efficacy of Veterinary Medicinal Products for Phage Therapy (18/10/2023)
• Enhanced Transparency: EMA's Revised Rules for Clinical Trials (11/10/2023)
• European Commission takes bold step to tackle microplastic pollution (09/10/2023)
• Update on web-based electronic Application Forms (eAFs) implementation (06/10/2023)
• Advancing Healthcare in Europe: EMA and EUnetHTA 21's Achievements (03/10/2023)
• CTIS News and Events (27/09/2023)
• Accelerating Clinical Trials in the EU: New Hub for Progress (22/09/2023)
• Advancing Pharmaceutical Safety: Jana Brajdih Čendak's Insights (22/09/2023)
• Join the DARWIN EU® Initiative: Collaborate with EMA for Real-World Healthcare Data (14/09/2023)
• EMA issues Concept Paper on Modern Manufacturing Techniques used for Herbal Medicinal Preparations (11/09/2023)
• PRAC recommends new measures to avoid topiramate exposure in pregnancy (04/09/2023)
• EU and US variation requirements (01/09/2023)
• Understanding Risk Management Plans in Pharmaceutical Development (30/08/2023)
• EMA released a draft Reflection Paper on the utilization of Artificial Intelligence (24/08/2023)
• Transition to IRIS Platform (17/08/2023)
• EUCROF Webinar: Application of Adverse Outcome Pathway (AOP) concepts in drug development. Moving towards the 3R goals for pharma industry (15/08/2023)
• EMA/HMA ePI Pilot Project (08/08/2023)
• New Ph.Eur. Monographs for Cannabis flower and Cannabidiol adopted by the EDQM (24/07/2023)
• Remote Batch Certification by the Qualified Person (QP) (20/07/2023)
• US FDA revised MAPP on cGMP Surveillance Inspections (10/07/2023)
• European Commision (EC) proposal for regulation of EMA fees (07/07/2023)
• EU Regulation with specific rules for Northern Ireland published (28/06/2023)
• EMA update on GACP Revision (28/06/2023)
• The Australian TGA is seeking feedback on the risk classification of medical devices (23/06/2023)
• Analytical Procedures for mRNA Vaccine Quality (USP Draft Guidelines) - 2nd Edition (16/06/2023)
• EMA updates Q&A documents on Centralised Procedures (13/06/2023)
• EMA: EU – US Mutual Recognition Agreement for Veterinary Medicines Inspections (06/06/2023)
• APIC published ICH M7 "How to Do" document (29/05/2023)
• What EMA publishes and when - Guide to information on human medicines evaluated by EMA (24/05/2023)
• EMA published Guidance for industry to prevent medicine shortages (22/05/2023)
• Medical Cannabis Act in Germany (22/05/2023)
• New EMA Guidelines and revisions in GMP Area (17/05/2023)
• APIC published document Data Integrity Frequently Asked Questions (FAQ) (15/05/2023)
• Guidelines for the implementation of Article 54 of the medicinal products act – the issue of marketing authorisation as an urgent measure (12/05/2023)
• Consequences from the new EU commission proposal on GMP (10/05/2023)
• Electronic Product Information (ePI) - TOPRA webinar with Katja Pečjak and Britt Vermeij as speakers (03/05/2023)
• PFAS ban Impact on Pharmaceuticals (25/04/2023)
• Modernization of the current variations system (24/04/2023)
• WHO published draft on revised GMP for excipients in pharmaceutical products (17/04/2023)
• What is ISO 13485 (14/04/2023)
• ICH publication of the introductory presentation on ICH Q9 (R1) (06/04/2023)
• EMA update on nitrosamines impurities (06/04/2023)
• Clinical Performance Study Protocol following the ISO 20916 (29/03/2023)
• The most important dates and requirements related to legacy devices (10/03/2023)
• DIA Session - Electronic Product Information For EU Medicines: The Road Ahead for the Implementation of the EU ePI (02/03/2023)
• ISO 20916 - clinical performance studies for IVD and ISO 14155 - clinical evaluation for MD (02/02/2023)
• Individual Deviation from the Terms of Marketing Authorisation (OOS) (01/02/2023)
• ICH published revised ICH Q9(R1) Quality risk management (31/01/2023)
• EMA’s 2023 Veterinary Info Day (27/01/2023)
• European Green Deal – draft regulation on packaging and packaging waste and impact on medicines (26/01/2023)
• FEES IN SLOVENIA AND CROATIA (25/01/2023)
• 3Rs Working Party (25/01/2023)
• Update on the EMA Checklists for Changes & Variations for Type II non-clinical variations (25/01/2023)
• EMA perspective on using mechanistic models to support development of complex generic drug products (19/01/2023)
• 10th Slovenian Meeting on Clinical Pharmacology: Safe Use of Medicines (16/01/2023)
• Artificial Intelligence in Regulatory Affairs? (16/01/2023)
• Educational Materials (12/01/2023)
• Clinical Trials Raw Data Pilot: first raw data submission has been received (10/01/2023)
• ICH: Draft Guideline for Bioequivalence Testing (10/01/2023)
• Role of EU Authorised Representative (09/01/2023)
• The European Commission has given the green light to an extension of the transition periods for the MDR and IVDR (06/01/2023)
• European MDCG group published Guidance on a Performance Study (06/01/2023)
• European Database on Medical Devices (03/01/2023)
• European Commission position paper on hybrid audits (21/12/2022)
• The future strategy for batch testing of medicinal products in Great Britain (19/12/2022)
• Danish Authority updated document on requirements for a Qualified Person (16/12/2022)
• An extension of the transitional period for MDR and IVDR (13/12/2022)
• Proposal for restriction on the placing on the market of microplastics (12/12/2022)
• Adoption of ICH Q13 guideline on continuous manufacturing (06/12/2022)
• EMA Risk Management Information Day (05/12/2022)
• Annex 1 - Final Version and its Impact - Current requirements on aseptic manufacturing (05/12/2022)
• European Commission changed labelling requirements for investigational medicinal products (05/12/2022)
• Public consultation on concept Paper on the revision of Annex 11 of the EU GMP – Computerised Systems (01/12/2022)
• IPEC has updated Excipient Stability Guide for Pharmaceutical Excipients (23/11/2022)
• US FDA Warning Letters of the fiscal year 2022  (21/11/2022)
• Consequences of Ban on Titanium Dioxide (E171) for Medicines? (17/11/2022)
• Vulnerabilities in global Supply Chains: Reasons and possible Solutions (15/11/2022)
• UK MHRA announces resumption of international GMP inspections (15/11/2022)
• DIFFERENT LABELLING OF MEDICINAL PRODUCTS (11/11/2022)
• MHRA announced the delay in implementation of British Medical Device Regulation (10/11/2022)
• Information about Marketed Medicinal Products (02/11/2022)
• Transition to the MDR and IVDR (28/10/2022)
• Draft Guidance on boundary and combination products published by TGA (27/10/2022)
• Person Responsible for Pharmacovigilance (26/10/2022)
• Two Compliance Program Guides (CPGs) on GMP inspections updated by US FDA (26/10/2022)
• Requirements for documentation in Annex II (24/10/2022)
• PHARMACOVIGILANCE WORLD 2022 (22/10/2022)
• The CHMP recommended granting marketing authorisation for Dengue Tetravalent Vaccine (20/10/2022)
• EMA published revised Q&A for marketing authorisation holders on nitrosamine impurities in human medicinal products (20/10/2022)
• The importance of mitochondrial toxicity assessment in drug development (18/10/2022)
• European Pharmacovigilance Congress 2022 (07/10/2022)
• EMA published draft Quality Guidelines for Synthetic Peptides and Oligonucleotides (29/09/2022)
• FDA issued draft data integrity guidance Computer Software Assurance for Production and Quality System Software for consultation (26/09/2022)
• Good documentation practices in GMP and GDP regulated environments (22/09/2022)
• USP and FDA Propose Updates to Good Storage and Distribution Practices (19/09/2022)
• TOPRA annual symposium 2022 (17/09/2022)
• 11th Symposium on Herbal Medicinal Products in Europe 2022 with Satellite Symposium on Medicinal Cannabis (05/09/2022)
• i-SPOC registration deadline by 2nd September (02/09/2022)
• EMA has published 3-year work plan for the Quality domain (31/08/2022)
• Amendment of the Rules on technical and organisational measures for the storage of hazardous chemicals (30/08/2022)
• TOPRA in CEE: Labelling of Marketed Drugs in CEE Region (27/08/2022)
• Update on EMA's Question and Answer document for MAH’s regarding nitrosamine impurities (25/08/2022)
• The CEP of the future, EDQM, workshop with stakeholders (21/08/2022)
• Data Integrity in GMP environment (18/08/2022)
• Revised GAMP®5 guidelines published (11/08/2022)
• Sodelavec za registracije (Regulatory Affairs Manager) m/ž (10/08/2022)
• European Commission published common specifications for certain high-risk IVD’s (09/08/2022)
• US FDA revises Guidance for industry – Non-penicillin beta-lactam drugs: A CGMP framework for preventing cross-contamination (09/08/2022)
• EMA to address nitrosamine impurities in upcoming revision of active substances guidance (05/08/2022)
• Microbial monitoring of compressed gases used in pharmaceutical manufacturing (01/08/2022)
• Status of implementation of the “Whistleblower” Directive (29/07/2022)
• US FDA published new guidances for industry (27/07/2022)
• FDA Approved? (22/07/2022)
• Planned revision of USP Description and relative solubility reference table (21/07/2022)
• Management of changes to authorized biocidal products (14/07/2022)
• Introductory training on ICH Q3D(R2) Guideline for Elemental Impurities (13/07/2022)
• EMA has published the Questions and Answers on titanium dioxide (04/07/2022)
• EMA updated IRIS Guide for applicants (01/07/2022)
• US FDA revises Guidance for industry – Non-penicillin beta-lactam drugs: A CGMP framework for preventing cross-contamination (29/06/2022)
• USA FDA proposes new Rules for Wholesale drug distributors and Third-Party logistics providers (28/06/2022)
• Gap analysis of quality management system in GMP environment (23/06/2022)
• Upcoming changes to REACH information requirements (22/06/2022)
• Supplier audit management (21/06/2022)
• EMA publishes annual report 2021 on 10th June, 2022 (20/06/2022)
• Labelling requirements for investigational medicinal products (16/06/2022)
• Importation of medicinal products in EU and new Annex 21 (15/06/2022)
• Cannabidiol novel food evaluations on hold due to data gaps and uncertainties about potential hazards related to CBD intake (14/06/2022)
• EMA adopts first list of critical medicines for COVID-19 (09/06/2022)
• Update of Q&A list for the submission of variations for human medicinal products (08/06/2022)
• Standalone Regulations for In vitro Diagnostic Medical Devices in Switzerland (06/06/2022)
• New template for the nitrosamine risk evaluation (03/06/2022)
• Distribution of medicinal products requiring special storage conditions (02/06/2022)
• EMA publishes final guidelines on quality and specifications for herbal medicinal products (01/06/2022)
• Theranostics: patient-centered care at its best (30/05/2022)
• Supplier management in pharmaceutical environment (30/05/2022)
• Reminder for in vitro diagnostic medical device sector: IVDR is now fully applicable (27/05/2022)
• EMA has updated Good Clinical Practice Annexes (26/05/2022)
• Revised ICH Q3D (R2) Guideline on elemental impurities (25/05/2022)
• Japan’s PMDA published English version of the revised global principles for clinical trials (19/05/2022)
• EMA updates Questions & Answers on Parallel Distribution (18/05/2022)
• 18th Adaptation to technical and scientific progress to Regulation (EC) No 1272/2008 (CLP Regulation) was published on 3rd May 2022 (17/05/2022)
• Public consultation concerning the physical attendance and the location of personal residency of the QP (17/05/2022)
• EMA’s update on Mutual Recognition Agreements (12/05/2022)
• Future of Pharmacovigilance (11/05/2022)
• CMDh Best Practice Guide for authorisation of Non-Prescription Medicines in the DCP and MRP (10/05/2022)
• Validation of excel spreadsheets (09/05/2022)
• EMA has released comments on the current ICH guideline Q9 (R1) quality risk management (05/05/2022)
• Brexit (04/05/2022)
• Revised US FDA Quality-Metrics program (03/05/2022)
• Targeted revision of the Cosmetics Regulation (02/05/2022)
• Monitoring of microbial contamination of sewage drains in manufacturing premises (28/04/2022)
• Total organic carbon test (TOC) (27/04/2022)
• EMA's expectations for bootstrapping (26/04/2022)
• FDA issues final guidance regarding Bioavailability Studies in NDAs or INDs (25/04/2022)
• Two CMDh guidance documents recently changed (22/04/2022)
• ICH Harmonized Guidelines Q14 and Q2(R2) (20/04/2022)
• A look at batch record review (19/04/2022)
• WHO publishes practical guide on how to temperature map cold chain equipment and storage areas (14/04/2022)
• TGA updated the quality rules for medicinal cannabis (13/04/2022)
• Implementation and preparedness plan of the IVDR endorsed by MDCG (12/04/2022)
• Slovenian SIQ newly designated notified body (04/04/2022)
• France enters the medical cannabis industry (01/04/2022)
• Combination Products and EU MDR 2017/745 Regulation (30/03/2022)
• European Commission approach for pharmaceuticals in the environment (30/03/2022)
• EMA’s extended mandate (29/03/2022)
• Risk Assessment of GDP Supply Chain Routes (28/03/2022)
• Certificate of Suitability (CEP) applications (25/03/2022)
• Regular interval for GDP Self-Inspections? (24/03/2022)
• Generic Drug Science and Research Initiatives Public Workshop (24/03/2022)
• Data Analysis and Real World Interrogation Network (DARWIN EU) (23/03/2022)
• EU GMP Annex 1 Manufacture of sterile medicinal products (23/03/2022)
• EU MDR and its impact on Swiss - EU relations (22/03/2022)
• Clinical Trials Information System (CTIS): Walk-in clinic (22/03/2022)
• GMP/GDP and GCP (21/03/2022)
• Pharma adopting to green initiatives (21/03/2022)
• Medicinal products containing estragole (17/03/2022)
• Future of United Kingdom clinical trial legislation and impact on IMP’s (17/03/2022)
• Clinical Trials during the COVID-19 Pandemic (16/03/2022)
• Electronic instructions for MD (15/03/2022)
• Veterinary medicines (14/03/2022)
• Nitrosamine risk assessments (11/03/2022)
• Good agricultural and collection practice (GACP) (10/03/2022)
• GMP guide (07/03/2022)
• Future of TiO2 (05/03/2022)
• Medical Devices (04/03/2022)
• Investigational medicinal products (IMPs) (03/03/2022)
• Focus on ensuring a high and reproducible quality of medicinal cannabis (01/03/2022)
• Published Annex 21 to the EU-GMP Guidelines (28/02/2022)
• The Clinical Trials Information System (CTIS) has gone live (13/02/2022)
• Our new Director of Regulatory Affairs (18/08/2021)
• MDR (26/05/2021)
• TiO2 safety (06/05/2021)
• Medical translations (18/09/2020)
• ENVIRONMENTAL RISK ASSESSMENT (ERA) (12/06/2020)
• GCP AUDITS (22/04/2020)
• BPE offers you a PRRC for your Medical Devices (09/03/2020)
• Billev Pharma East was managing the whole decentralized regulatory procedure to gain approval (09/02/2020)
• Let’s meet at the 13th Pharmacovigilance Conference (10/01/2020)
• Approaching deadline for reporting the outcome of nitrosamine risk evaluations (09/01/2020)
• BPE can offer you a contractual PRRC for your Medical Devices (23/07/2019)
• Billev Pharma East can help you with QP release and GMP audits preparation (29/03/2019)
• Are you ready for Brexit? (24/02/2019)
• Billev Pharma East at the annual Pharmacovigilance and Regulatory Affairs Conference 2019 (13/02/2019)
• Updates to eAFs (06/02/2018)
• Updates to eAFs (06/02/2018)
• Billev Pharma East experience from conference in London (05/02/2018)
• Billev Pharma East experience from conference in London (05/02/2018)
• FDA’s May 2018 eCTD deadline (30/01/2018)
• PhV and RA conference in London from 24th-26th of January (09/01/2018)
• SPOR going live 15 December 2017 (15/12/2017)
• Let’s meet at the 11th Pharmacovigilance Conference (23/11/2017)
• NeeS is out from MRP (eCTD only for all submissions in EU procedures) from 1 January 2018 (13/11/2017)
• Pharmacovigilance Conference (08/11/2017)
• CPhI Worldwide, Frankfurt (16/09/2017)
• BREXIT (16/09/2017)
• Health-Based Exposure Limits (HBELs) (13/09/2017)