Embed Size (px)
Citation preview
MEDIA INFORMATION
CONTACT [email protected] T + 44(0)207 2372036
IPI EDITORIAL CALENDAR 2018
IPI – International Pharmaceutical Industry is peer reviewed. Supported by a team of industry experts, IPI brings you
contemporary and authoritative articles which will guide the industry in the best practice in regulatory issues, market
analysis, drug discovery, development, delivery methods, clinical research, laboratories, analytical testing, custom and
contract manufacturing, primary and secondary packaging and logistics and supply chain management.
Please visit our website www.ipimediaworld.com, to view our Peer review protocol, and author guidelines.
EDITORIAL SECTIONS
Regulatory and Marketplace Drug Discovery, Development
& Delivery
Clinical & Medical Research Laboratories
Logistics & Supply Chain Manufacturing
Management
Packaging Information Technology
For Events & Conferences attended by IPI, please visit our website at - www.ipimediaworld.com
Regulatory & Marketplace The changes to the EU regulatory requirements for medical devices
The new EU regulations: increasing the compliance requirements for
manufacturers; tougher requirements for quality systems, post-
market surveillance, and device submissions
The new requirements for post-market surveillance reporting
requirements
Navigating the regulatory requirements in product development
The regulation and supply of drugs in the post-Brexit era
Drug Discovery, Development and Delivery New technologies for reducing the cost and lead time of drug
development
Biologics, a game-changer in treatments delivered by self-injection
Biotech ways of improving the productivity of drug development:
rational drug design, combinatorial chemistry, in silico
experimentation
Analytical technology for biopharmaceuticals
Transforming information management: the updated EU
pharmacovigilance legislation and the eECD
The rising tide of functional data from study of the human and other
genomes, aiding in drug discovery
The penetration of biologic drugs: monoclonal antibodies,
recombinant proteins, peptides, cell and gene therapy products.
Clinical & Medical Research Discussing the financial challenge to run a PMA study
Strategic alignment of study objectives and endpoints to drive value
and fill data gaps
Medical Affairs approach to developing and implementing clinical
studies (Phase I to IV)
Understanding the challenges in designing and executing clinical
trials for screening tests
Comparing the difference between clinical trials for screening tests
and clinical trials for traditional medical devices/in-vitro diagnostic
tests
Patient recruitment and retention in clinical development
Mergers and acquisitions of pharma and biopharma companies
How the focus on personalised medicine is shaping the industry
Biologics research services and the new technology platforms for
high-throughput screening
Technology Optimising clinical trials through Data and technology
Validation of IT systems used for data storage and reporting
Dealing with a complex IT environment, which includes data on
multiple systems in different formats
The e-Recruitment
Logistics & Supply Chain Management Achieving traceability and transparency across the entire
supply chain
The importance of data validation and its effects on supply
chain management
Insights into trends, challenges and opportunities having an
impact on healthcare logistics
Supply chain security: measures to comply with the Falsified
Medicine Directive (FMD)
Integration of medical apps
Integrating Serialisation and Track and Trace Systems into
the Supply Chain
Manufacturing How to shorten the time and lower the cost of drug
development and manufacturing
Small molecule API process development
Clean rooms and APi films – the changes in industry
standards (by 2020, plastics used in pharma manufacturing
will need to comply with the same standards as plastics
packaging used for finished pharmaceuticals)
Process development and new technologies for downstream
manufacturing
New cell culture techniques
Prefilled syringe fill-finish equipment
Turnkey solutions
Clean room and contamination control
Customised pharmaceutical technologies
Single-unit dosage forms (effervescent tablets,
Blow-fill-seal vials)
Lyophilisation & Freeze Drying
Suitability of formulations
Packaging The implications of mandatory serialisation
The challenges of packaging biologics
Track and trace technologies
Blister packaging – improving dose compliance and safety
Liquids and sachets
Serialization and worldwide track and trace compliance
strategies
Stability testing & shelf life
Laboratories Innovations in LIMS
Laboratory asset management services
The new electronic laboratory notebooks
Volume 10 Issue 1
Editorial Submission Deadline: 29th January 2018
For Events & Conferences attended by IPI, please visit our website at - www.ipimediaworld.com
Regulatory & Marketplace Recent developments in cellular immunotherapy: IP and patents
Medical devices: FDA cyber security regulatory update
The business case for the identification of medicinal products
(IDMP) implementation
Marketing authorisation, regulatory requirements and strategies
The new mandatory inclusion of data sourced from clinical
investigations for new Class III or implantable medical device
applications
Drug Discovery, Development and Delivery
High throughput proteomics work stations for applications such
as MALDI TOF MS target spotting and protein crystallization
Work stations, automating assays, and sample preparation
during every phase of the drug discovery process
Current methods of rational drug design
High throughput screening, databases and proprietary
algorithms
Products for virtual screening and database building
The convergence of informatics and wet lab experimentation in
the drug discovery process
Advancements in drug discovery technologies: such as iPS
cells, automated high content screening, patch clamp, gene
editing and DNAencoded libraries
Clinical & Medical Research Patient centricity in clinical trials – the FDAs Patient-Focused
Drug Development
Use of investigative sites in Central & Eastern Europe for clinical
studies
The new EU clinical trials regulations
The importance of Subject Recruitment and Retention to clinical
trial success
Lessons learned and ways forward
FDA` Post-marketing safety surveillance program for drug and
therapeutic biologic products
The promise of reporting systems in patient safety
Emerging role of bioinformatics tools in the evolution of clinical
research
Genomics and Proteomics Research
Technology The graph database technology
The next-generation RBM approach/RBM solutions
The e-way – EDC
Trends in clinical trials management systems
Logistics & Supply Chain Management Temperature control
Regulatory compliance
Supply chain visibility
Optimisation and cost management
The impact of digitalisation
The Big Data Revolution
Planning and Preparing for the Next Step: Driving Business
Value Beyond Compliance
Manufacturing Strategies for the control of visible particles in manufacturing of
sterile devices
Quality metrics for pharmaceuticals: how to use data analysis to
drive process improvement
Product security
Bioprocessing
Bioprocessing: single-use systems and disposable devices
Protein biopharmaceuticals
Vial and cartridge fill-finish equipment
New manufacturing technology platforms for Biosimilars
Pharma facilities: modular design
PAT Quality by Design
Turnkey solutions
Tablet-coating technologies
Packaging Smart label technology
Filling and Closing technologies
Anti-counterfeiting technology solutions
Prefilled syringes
Pre-fillable syringes – integrating drug delivery platforms and
single-dose- unit forms
Prefilled injection systems
Mass customization of packaging for use in multiple markets
Advanced aseptic processing technology: the blow-fill-seal
process
Braille Packaging
Thermal packaging /Insulated shipping
Laboratories Biochips
Lab on a chip
DNA and Protein microarrays
Volume 10 Issue 2
Editorial Submission Deadline: 29th April 2018
For Events & Conferences attended by IPI, please visit our website at - www.ipimediaworld.com
Regulatory & Marketplace The expanding role of Pharmacovigilance in product
development
Mergers and acquisitions/ Responding to the shifting market
dynamics
The rise of generic drugs/The international harmonisation of
product information
Safety and regulatory solutions for biopharmaceutical
companies
Drug Discovery, Development and Delivery Emerging Trends in Healthcare and Drug Development
Optimizing bioavailability using particle engineering, improving
drug safety and ADME, and genomics.
The emergence of value-based reimbursement models
The healthcare digitization trends
Biomarker identification for targeted therapies
The new business model known as insourcing: a new sourcing
for pharma where CROs work on-site at customer location in
an integrated fashion
Building capabilities to differentiate in the area of Target
Identification/Target Validation
Clinical & Medical Research The growing identification of combinatorial chemistry
technology
Regulatory initiatives fostering demand for pharmacogenomics
technology
Proteomics in anticancer drug discovery
Human protein microarray for various protein analysis
Avoiding hidden costs in conducting clinical trials
Trial Design
Site Selection
Data management/biometrics/medical writing
Panel screening, enzymatic, and binding assays
Target validation, efficacy, and safety studies
Technology Is Data the new Oil?
New methods of data management: IT solutions that can
transform data into knowledge
Dealing with Data
Logistics & Supply Chain Management GDP requirements: the understanding and application of
Quality Risk Management (QRM)
The control of outsourced transportation activities
The importance of identifying and supporting acceptable levels
of risk in regards to temperature excursions and proactive
oversight
Manufacturing Turnkey solutions
Process control and automation
Clean rooms and contamination control
Single-unit dosage forms
Lyophilisation & Freeze drying
Trends in product filling: pre-sterilised, single-use systems
Cleanrooms: design, testing and operations
Leak detection systems
Optimising solid dosage manufacturing
Innovation in Lyophilisation
Process Control and Automation
Bioprocessing
Bioprocessing: single-use systems and disposable devices
Protein biopharmaceuticals
Vial and cartridge fill-finish equipment
New manufacturing technology platforms for Biosimilars
Packaging Plastic-free blister packs
Mass customisation of packaging
Thermal packaging
Translation and licence regulation
Tackling patient adherence challenges
Sterile packaging/sterile closures
Sterile fill finish
Patient- centric packaging – child resistant/senior friendly
Pre-fillable syringes – integrating drug delivery platforms and
single-dose- unit forms
Prefilled injection systems
Mass customization of packaging for use in multiple markets
Laboratories Laboratory information management systems
The changing laboratory marketplace
Breakthrough developments in laboratory testing technology
Volume 10 Issue 3
Editorial Submission Deadline: 29th July 2018
For Events & Conferences attended by IPI, please visit our website at - www.ipimediaworld.com
Regulatory & Marketplace Using CROs to optimise patient recruitment in clinical trials
Considerations for Outsourcing the clinical, safety and regulatory
activities
SMEs: addressing the challenge of developing and maintaining
effective clinical, safety and regulatory operations
IP strategies
Drug Discovery, Development and Delivery Building capabilities to differentiate in the area of Target
Identification/Target Validation
Novel therapeutics addressing the unmet needs
Use of next-generation sequencing in-vitro diagnostics
Opportunities for biologics delivery
Evolving business models including risk-based and insourcing are
facilitating better collaboration between pharmaceutical
companies and CROs.
Clinical & Medical Research Assessing complexity of study design and matching to systems
based on efficiency and cost-effectiveness
Evaluating needs and available in-house resources for managing
data and regulatory documentation
Testing usability for investigational site staff and sponsor
data/regulatory documentation management
EDC builds: Outsourcing or use of in-house resources (impacted
by study complexity, system capabilities and costs)
How patient inspired solutions are globally connecting healthcare
and clinical research by empowering and enabling connectivity
between sites, sponsors, CROs, IRBs and other industry
stakeholders
Accomplishing quality study data to improve reimbursements and
increase market access
Planning a global trial
Technology The development of wearable technology
Automating data collection
Developing open-source data platforms
Logistics & Supply Chain Management The `last mile` in the supply chain
Achieving supply chain flexibility: 3PL partnerships
IoT solutions
Supply chain innovations
The issue of `modal shift`: air freight versus sea freight
The sustainability issue: Leaner and Greener
Data delivery: how to collect, analyse and package data for
success.
Manufacturing Solid dose manufacturing
Parenterals
Vaccines
Barrier isolation
The challenge of containment
Cleanroom technology: latest news and technical
developments
Filtration & Separation
PAT Quality by Design
Turnkey solutions
Environmental protection & facility management
FDA & EMEA facility compliance
Packaging Stability testing
Packaging’s role in Drug security and safety
Sterile packaging
The importance of data accuracy, global compliance and
serialisation processing
Drug labelling
Meeting the New Serialisation Requirements
Trends and Needs in Packaging: Plastic Bottles
Pre-fillable syringes – integrating drug delivery platforms and
single-dose- unit forms
Prefilled injection systems
Mass customization of packaging for use in multiple markets
Translation & Licence regulation
Patient information leafleting
Laboratories Genetic testing
Point-of-care testing (POCT)
Volume 10 Issue 4
Editorial Submission Deadline: 28th October 2018
CONTACT
International Pharmaceutical Industry Tower Bridge Business Complex 100 Clements Road London – SE1 5RT T: +44 (0) 207 2372036 E: [email protected] W: www.ipimediaworld.com
Advertising Contact: Anthony Stewart [email protected]
Editorial Cecilia Stroe [email protected]
Production Virginia Toteva [email protected]
Subscriptions Martin Wright [email protected]
