Corporate Banner
Satellite Banner
RNAi
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - June 2013


Technology Transfer

26 Jun 2013 - 28 Jun 2013 - London, UK



Bookmark and Share


This three-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring manufacturing technology and to highlight some proven techniques for overcoming those challenges.


The focus of the course is on small-molecules and their formulations rather than biological products, although many of the issues faced and techniques discussed will be equally applicable.


Some of the benefits to be derived from this workshop include:

  • An appreciation of where TT fits in the life cycle of a pharmaceutical product.
  • An appreciation of the importance of planning and project management in TT
  • An overview of the potential complexity of technology and product transfer.
  • An outline of proven best practice in technology transfer.
  • An opportunity to discuss current issues and challenges in technology transfer with peers and with an expert faculty.
  • A consideration of 'where next' as we move from traditionally-developed products to a world where products are developed using QbD techniques and controlled by PAT.

Who Should Attend?

Pharmaceutical technologists, Quality Assurance staff, Regulatory staff, Engineering staff, Project Managers and anybody else involved in the transfer of products or technology from one location to another.

Course Programme

Day 1

Why Transfer Technology?

Pharmaceutical Product Life Cycle

  • Development
  • Innovative
  • Mature
  • Generic

Product Transfers and Technology Transfers

  • IP
  • Technology
  • Techniques
  • Regulatory Considerations

Registration Procedures

  • Europe
  • Non-European

Variation Procedures

  • Types of Variations
  • Advantages and Disadvantages

Day 2

Technical Challenges

  • Manufacturing processes
  • Validation
  • Stability
  • Packaging processes

Logistical Challenges

  • Label Changes * Text * Physical
  • Timing * Project Plan * Phase in/out

Day 3

Technical Challenges (2)

Impact of new technology

  •  Quality by Design
  •  Process Analytical Technology

Human Challenges

  • Push versus Pull
  • Team membership and team roles
  • Cross-Cultural Issues
  • Progress Reporting and breaking bad news


Further information
Scientific News
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
New Tool For Investigating RNA Gone Awry
A new technology – called “Sticky-flares” – developed by nanomedicine experts at Northwestern University offers the first real-time method to track and observe the dynamics of RNA distribution as it is transported inside living cells.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
New Weapon in the Fight Against Blood Cancer
This strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
TOPLESS Plants Provide Clues to Human Molecular Interactions
Scientists at Van Andel Research Institute have revealed an important molecular mechanism in plants that has significant similarities to certain signaling mechanisms in humans, which are closely linked to early embryonic development and to diseases such as cancer.
Toxin from Salmonid Fish has Potential to Treat Cancer
Researchers from the University of Freiburg decode molecular mechanism of fish pathogen.
Scientists Create CRISPR/Cas9 Knock-In Mutations in Human T Cells
In a project spearheaded by investigators at UC San Francisco, scientists have devised a new strategy to precisely modify human T cells using the genome-editing system known as CRISPR/Cas9.
Long-sought Discovery Fills in Missing Details of Cell 'Switchboard'
A biomedical breakthrough reveals never-before-seen details of the human body’s cellular switchboard that regulates sensory and hormonal responses.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!