2018 EDITORIAL COVERAGE. Connecting the Pharma Industry for 28 Years.

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1 2018 EDITORIAL COVERAGE Connecting the Pharma Industry for 28 Years

EDITORIAL COVERAGE: EXPERT INSIGHT AND ANALYSIS Pharmaceutical Technology Europe sets the standard for publishing independent, industry-leading information on the technologies, strategies, and

2 EDITORIAL COVERAGE: EXPERT INSIGHT AND ANALYSIS Pharmaceutical Technology Europe sets the standard for publishing independent, industry-leading information on the technologies, strategies, and regulations crucial to professionals developing and manufacturing pharmaceuticals and biopharmaceuticals. The editorial mix of peer-reviewed papers, technical articles, technology reports, regulatory and business columns, and expert commentary provide comprehensive coverage of process and formulation development, manufacturing operations, drug delivery, packaging, labelling, and distribution. EDITORIAL FOCUs Each issue of Pharmaceutical Technology Europe addresses a key trend in drug development. Through expert interviews, roundtable discussions, literature reviews, and survey analysis, the editors report on emerging trends, strategies, and best practices in these key areas. PEER-REVIEWED REsEARCH Pharmaceutical Technology Europe publishes peer-reviewed papers in the form of data-driven research papers, literature and patent reviews, application and technical notes, and position papers on a broad range of drug development topics. All papers undergo a double-blind peer-review process by the Pharmaceutical Technology Europe Editorial Advisory Board, which consists of leading scientists, managers, directors, and consultants. KEY TOPICs Drug Features address formulation and drug delivery challenges including solubility, particle engineering, traditional and emerging dosage forms, and more. Advances in API synthesis of small- and large-molecule drug substances, as well as excipients to enhance drug properties, are also addressed. A special column provides thought-leader insight on drug development activities in Europe. MANUFACTURING AND OPERATIONs The editors examine problems and solutions for solid dosage, sterile, biopharmaceutical, and other drug forms. Experts share insights on manufacturing equipment, process controls, scale-up, packaging, tech transfer, and facility and laboratory operations. ANALYTICAL TEsTING Feature articles and case studies address vital quality and characterization practices including elemental impurities, stability testing, protein characterization, microbial contamination, method development, and more. QUALITY/REGULATIONs Experts review current regulatory authority initiatives and offer insight on quality agreements, critical quality attributes, investigations, process validation, statistical practices, and more. supply CHAIN Supply chain coverage includes equipment, software, and services to maintain a secure, compliant serialization program, take proactive measures against counterfeiting, ensure safe shipping, and other supply chain issues. OUTsOURCING Trends, partnerships, and business activities in the contract services market are described by expert columnists. Other features examine best practices for working with contract service providers for drug development, manufacturing, or laboratory studies. CONTRIbUTION GUIDELINEs For information about contributing editorial features to Pharmaceutical Technology Europe, visit

JANUARY FEbRUARY MARCH Ad Close: 8 January Ad Close: 30 January Ad Close: 23 February 2018 Bio/Pharma Outlook API and Approval Trends Drug Addiction Prevention Biologic-Based Drug Industry 4.

3 JANUARY FEbRUARY MARCH Ad Close: 8 January Ad Close: 30 January Ad Close: 23 February 2018 Bio/Pharma Outlook API and Approval Trends Drug Addiction Prevention Biologic-Based Drug Industry 4.0/Internet of Things Process Validation Elemental Impurities Track and Trace/Serialization Review Pharmapack, 7 8 Feb., Paris Readex Ad Performance Study Free 1/2-Page Pharmapack Exhibitor Profile Seeking Analytical Answers Ensuring Excipient Quality Biologic Drug Formulation Solid/Semi-Solid Drug Single-Use Regulatory : Sterile/Aseptic Lab Data Integrity Facility Design and Anticounterfeiting PDA Europe - Parenteral Packaging, February, Rome, Italy Global Drug Delivery & Formulation Summit, March, Berlin BIO-Europe Spring, March, Amsterdam Pittcon, 26 Feb. 1 March, Orlando, FL, USA Early Strategies Advances in API Synthesis Particle Engineering Topical Drug Process Quality Agreements Stability Testing Lab Cold Chain Review Special Themed Supplement Resources An annual review of the market for outsourced resources, including analysis of contract services and business, regulatory, and supply chain issues. DCAT Week, March, New York INTERPHEX, April, New York 1/3-Page Product/Service Profile

APRIL MAY JUNE Ad Close: 26 March Ad Close: 25 April Ad Close: 24 May Modernizing Pharma Selecting API Suppliers Protein/Peptide Delivery Inhalation Drug Equipment and Batch Records Protein

4 APRIL MAY JUNE Ad Close: 26 March Ad Close: 25 April Ad Close: 24 May Modernizing Pharma Selecting API Suppliers Protein/Peptide Delivery Inhalation Drug Equipment and Batch Records Protein Characterization Statistical Solutions Tech Transfer Certificates of Analysis CPhI North America, April, Philadelphia Informex, April, Philadelphia Making Pharmaceuticals, April, Coventry, UK Process Optimization Biopharmaceutical APIs Capsule Formulations Aseptic/Sterile Drug Data Integrity Regulatory : Solid/Semi-solid Dosage Cleaning Validation Logistics/Shipping Review BIO International Convention, June 4 7, Boston ACHEMA, June, Frankfurt 1/3-Page Product/Service Profile 1/2-Page Achema Exhibitor Profile Emerging Drug Delivery Trends Continuous API Solubility/Bioavailability Biologic-Based Drug Fill/Finish Critical Quality Attributes Dissolution Testing Process Clinical Trial Materials Logistics Outsoucing 3rd PDA Europe Annual Meeting, June, Berlin, Germany ChemSpec Europe, June, Cologne, Germany

5 JULY august september Ad Close: 26 June Ad Close: 27 July Ad Close: 23 August Sustaining Good Practices Excipients for Controlled- Release Formulations Expression Systems Aseptic/Sterile Drug Process Control/Automation Corrective Action and Preventive Action Particle Characterization Track and Trace/Serialization Review Controlled Release Society, July, New York 1/3-Page Product/Service Profile Building Better Biologic Drugs Hazardous Reagents Tablet Formulation Solid/Semi-Solid Drug Modular Systems Investigations/Root Causes Extractables and Leachables Testing Lab Good Distribution Practices Special Themed Supplement APIs, Excipients, and featuring the CPhI/ICSE Worldwide Planning Guide s in the synthesis of APIs and pharmaceutical intermediates, plus advances in small-molecule synthesis, biologics manufacturing, formulation development, and finished-product manufacturing. This issue will feature a CPhI Planning Guide. Digital distribution to 44,500 CPhI visitors and 2,500 CPhI exhibitors Security Repurposing APIs Taste-masking Biologic-Based Drug Clinical Trial Materials Quality by Design Microbial Contamination Statistical Solutions Facility Design and Anticounterfeiting/Theft Avoidance Review PPMA, Sept., Birmingham, UK CPhI Worldwide, 9 11 Oct., Madrid, Spain Free 1/2-page CPhI Worldwide Exhibitor Profile PDA Europe - Pharmaceutical Freeze Drying Technology, September, Cologne, Germany Readex Ad Performance Study SHOW ISSUE

6 OCTObER NOVEMbER DECEMbER Ad Close: 27 September Ad Close: 25 October Ad Close: 22 November Drug Dosage Forms Trends Advances in the API Synthesis Lab Lipid-Based Formulations Solid/Semi-Solid Drug Lyophillization Mock Inspections Lot Release Testing Raw Materials Tracking Outsoucing AAPS 2018 PharmSci360, 4 7 Nov., Washington DC PDA Europe & Contract / Pharmaceutical Cold Chain & Logistics 1/3-Page Product/Service Profile Avoiding CMC Roadblocks High-Potency API Prefilled Syringes Aseptic/Sterile Drug Process Modeling Risk Assessment and Mitigation Visual Inspection Techniques Tech Transfer Drug Product Tracking Review CPhI India, 4-6 Dec., Mumbai The Quality Issue Special Report: Salary and Employment Survey Biopharmaceutical APIs Combination Products Transdermal Drug Scale-Up Standard Operating Procedures Endotoxin Testing Process Validating Supplier Quality Free Full-Page Corporate Profile Editorial content may change at the discretion of the editor. *Advertising deadlines may be subject to change. ** Receipt of an article or abstract does not guarantee inclusion in a particular issue of the magazine or on

Introduction to CMC Regulatory Affairs

Introduction to CMC Regulatory Affairs Bharathi Mamidipudi Regulatory Affairs Consultant II Syner-G Pharma Consulting, LLC Northeastern University, Boston November 10, 2016 My Background Experience ~4