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5209 Practical Approaches to Global GMP for Investigational Medicinal Products (Clinical Trial Materials)
Instructor:
» Dr David F. Bernstein and » Dr Klaus Kehne
Next course:
June 4-5 2009, Prague, Czech Republic
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
Price:
€ 1.795 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
» Dr David F. Bernstein and » Dr Klaus Kehne
Next course:
June 4-5 2009, Prague, Czech Republic
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
Price:
€ 1.795 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
Industry field:
Pharmaceutical industry, Final dosage form
Course description:
It is well understood that the principles of GMP must be applied once drug development has progressed to the human testing stage. Current EU and FDA Guidelines reflect the need for alternative approaches to regulatory compliance for many areas of IMP (CTM). In some cases, the uniqueness of IMP operations warrant reduced interpretation of GMP (for example, process validation); while in other areas, increased scrutiny are prudent for control of identically appearing drug products in look alike containers.
This program features in-depth discussions on each aspect of the unique GMP for IMP (CTM) and will include comparisons between the EU Annex 13 regulations, FDA Guidance and ICH Guidelines. We will focus on specific "how to" procedures that represent "best attainable practices" in those areas of GMP for IMP (CTM) that are most often questioned (expiration date on label, re-labeling extensions of the expiration date, responsibilities of the QP, EU required testing). The program will also feature small group problem solving sessions which will enhance the practical application of the concepts presented.
Course outline:
Professionals involved directly in the investigational material and clinical supply chain (manufacturing, packaging, labeling, testing, shipping). Professionals who are the customer for IMP (CTM) such as clinical research and medical professionals. Professionals who are responsible for regulatory and quality activities for IMP (CTM). The information presented and the small group workshop sessions will be of special interest to all professionals who interact with colleagues in other ancillary and peripheral disciplines involved in IMP (CTM).
Pharmaceutical industry, Final dosage form
Course description:
It is well understood that the principles of GMP must be applied once drug development has progressed to the human testing stage. Current EU and FDA Guidelines reflect the need for alternative approaches to regulatory compliance for many areas of IMP (CTM). In some cases, the uniqueness of IMP operations warrant reduced interpretation of GMP (for example, process validation); while in other areas, increased scrutiny are prudent for control of identically appearing drug products in look alike containers.
This program features in-depth discussions on each aspect of the unique GMP for IMP (CTM) and will include comparisons between the EU Annex 13 regulations, FDA Guidance and ICH Guidelines. We will focus on specific "how to" procedures that represent "best attainable practices" in those areas of GMP for IMP (CTM) that are most often questioned (expiration date on label, re-labeling extensions of the expiration date, responsibilities of the QP, EU required testing). The program will also feature small group problem solving sessions which will enhance the practical application of the concepts presented.
Course outline:
- Uniqueness of IMP (CTM) activities
- GMP differences between commercial products and IMP (CTM
- Global Regulations for GMP for IMP (CTM) [Annex 13, FDA Guidelines]
- similarities and differences and interpretations - Recommended Revisions to EU and FDA Guidelines
- IMP Practices at the Interface of GMP and GCP
- Question and answer session on impact of GMP controls on cutting edge technologies (automation, conserving study drug, double randomization, IVRS, Just in Time packaging, labeling and shipping) )
- Best Practices for IMP [each aspect of GMP will be explored using examples of best practice approaches]
- Daily workshops [a labeling workshop; a stability and expiration dating workshop]
- The new FDA Guidance document "INDs - Approaches to Complying with cGMP During Phase 1" [Optional discussion, time permitting]
Professionals involved directly in the investigational material and clinical supply chain (manufacturing, packaging, labeling, testing, shipping). Professionals who are the customer for IMP (CTM) such as clinical research and medical professionals. Professionals who are responsible for regulatory and quality activities for IMP (CTM). The information presented and the small group workshop sessions will be of special interest to all professionals who interact with colleagues in other ancillary and peripheral disciplines involved in IMP (CTM).
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com