Transdermal and Intradermal Drug Delivery Systems, 2018
Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines
September 6-7, 2018, Racquet Club of Philadelphia, PA
The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion by 2020. The industry is on the threshold of bringing into commercial production a new generation of transformative TDD and IDD therapies and delivery systems. That is why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.
Over 16 Featured Speakers, Including:
- Conor O'Mahoney, Tyndall National Institute
- Lisa Dick, 3M
- Bobby Singh, Corium
- Harvinder Gill, Texas Tech
- Yasmine Gomaa, Georgia Tech
- Audra Stinchcomb, F6 Pharma
- Ajay Banga, Mercer University
- Narasimha Murthy, Ole Miss
With Comprehensive Coverage on:
- Product Development and Quality Control Expectations with Respect to Transdermal and Topical Systems
- Key Formulation Considerations for Skin-Mediated Therapies and Vaccines
- Latest Advances in Microneedle Technology for Biologics
- Semisolids to Patches to Delivery Technologies: Unique IVPT Challenges As We Adapt the Franz Cell
- Novel TD Patch Designs and Technologies
- Heat Effects and IVIVC in Transdermal and Topical Drug Delivery
- In Vitro Permeation Testing of Dermal Products
- Understanding Regulatory Issues & Requirements for TDD & IDD Systems
- Overcoming Barriers to Large Molecule Delivery and Expanding the Range of Compounds for Use in TDD & IDD
- Scale-Up to Manufacture of TDDS and IDDS
- Risk-Based Strategies for TDD & IDD System Design
- Mechanisms of Dermal and Transdermal Absorption of Drugs
- In Vitro Release Studies for TDD & IDD
2018 Cleaning Validation Summit
Cleaning Standards For Drugs and Devices From Industry Experts
September 12-13, 2018, Philadelphia, PA
Are you up to speed on the Science, Risk and Statistics based approaches for Cleaning Validation? Today's regulators are now asking for, and expecting, ADE Monographs and Risk Assessments of Cleaning Validation Programs. This two-day, intensive summit brings together the industry leaders on science and risk and statistics based cleaning.
Over 15 Featured Speakers, Including:
- Scott Coburn, FDA
- Mohammad Ovais, Amgen
- Jessica C. Graham, BMS
- Andrew Walsh, Cleaning CPCI
- Fred Ohsiek, Bayer
- Igor Gorsky, Concordia Valsource
- Robert Jernigan, GSK
- Joe Cagnassola, Alcon
- Robert Kowal, Johnson & Johnson
- Mariann Neverovitch, BMS
- Thomas Altmann, Ecolab
- Beth Kroeger, Steris Corporation
- Stephen Spiegelberg, Cambridge Polymer Group, Inc.
Formulations Development: A Short Course
October 16-17, 2018, Racquet Club of Philadelphia
Presented by Dr. Ronald D. Snee
This course will help scientists and engineers develop formulation recipes more quickly and efficiently. Good strategies are needed to get the right data in the right amount at the right time. Dr. Ronald Snee has worked on this problem for decades and has executed many different types of these experiments in a variety of industries. This experience has enabled him to identify what is essential for successful designs rather than what is just nice to know. Participants will be able to immediately apply what they have learned.
Including Comprehensive Coverage On:
- Approaching formulation development from a strategic viewpoint.
- Generating the right data in the right amount at the right time.
- Designing screening experiments to identify those components that are most important to the performance of the formulation.
- Designing optimization experiments to identify optimum responses in the design space (operating window).
- Analyzing both screening and optimization experiments using graphical and numerical methods.
- Creating formulation design spaces and perform associated risk analysis
- Optimizing multiple criteria, such as the quality, cost, and performance of product formulations.
- Designing and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%.
- Reducing mistakes, better meet deadlines, avoid wasted experimentation and reduce the cost of experimentation in terms of time, personnel and funds.
About Your Instructor:
Ronald D. Snee is President of Snee Associates, LLC. He provides guidance to senior executives in pursuit of improved business performance using Quality by Design, Process Modeling, Lean Six Sigma and other improvement approaches that produce bottom line results. His work focuses on the pharmaceutical and biotech indus- tries. He is an Adjunct Professor in the pharmaceutical programs at Rutgers and Temple Universities.
For half a century Dr. Snee has been a leader in the field of statistical applications in the pharmaceutical, biotechnology, and petroleum industries. He received his BA in Mathematics from Washington and Jefferson College and MS and PhD degrees from Rutgers University in Applied and Mathematical Statistics. He is a Fellow of the American Society of Quality, the American Statistical Association, and the American Association for the Advancement of Science. He has been elected as an Academician in The International Academy for Quality. He has been recognized by 20 major awards and honors including the ASQ Distinguished Service Medal, ASQ Grant Medal and the ASA Deming Lecture Award. He has published five books and more than 235 papers in the fields of statistics, performance improvement, and quality management. His most recent book is: Strategies for Formulation Development, which is the subject of this workshop.
Early Bird Special: Register by August 1st for only $1,195!
Extractables, Leachables & Elemental Impurities 2018 - West Coast
Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics
November 13-14, Sheraton La Jolla, CA
This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, and parenteral drug products. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.
With Representation From:
- VR Analytical
- Jordi Labs
- West Pharmaceutical Services
- EKG Labs
- Material Needs Consulting
- Nelson Labs
Featuring Comprehensive Coverage On:
- Key Issues in Satisfying ICH Q3D, and USP Guidelines Regarding Elemental Impurities (EI)
- Update on revised USP for Materials and Components used in Pharmaceutical Manufacturing Systems
- Update on Revision of USP for Plastic Material Components and Packaging Systems
- Update on revised USP for EI and Extractables for Elastomeric Enclosures in Injectable Devices
- Analytical Challenges in Extractable and Leachable Studies of Pre-Filled Syringes for Oil-Based Drug Formulations
- PQRI Thresholds and Best Practices for E&L for Biologics
- Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
- E&L Considerations in the Qualification and Validation of Single-Use Systems
- Toxicology Assessment Approaches for E&L Studies
- E&L for Oral Dosage Forms
- Addressing Extractables & Leachables from Bioprocessing Equipment & Product Packaging
- And More!
Early Bird Special: Register by August 15 and Receive a $200 Discount off the Standard Rate!!
Happy Hour Sponsor:
Pre-Filled Syringes- February 27-28, 2019
Data Integrity & Pharmaceutical Quality Compliance- March 2019
Extractables, Leachables and Elemental Impurities - March 2019
Pharma Analytics Summit- June 2019
Inhalation Drug Delivery Systems- June 2019
Aseptic Manufacturing- September 2019
San Diego, CA
Transdermal Drug Delivery Systems- September 2019
Cleaning Validation - October 2019
Process Validation- November 2019
San Diego, CA
Technology Transfer - November 2019