Solid oral dosage forms are the most popular and convenient type of medicinal product. This workshop deals with the important steps in developing these types of drug products, from the pre-clinical stage to regulatory approval. The topics covered include the goals of the development project, organization of the drug development team, formulation/process development, analytical controls, stability evaluation and establishing bioequivalence. The course material will include examples of common pitfalls, reasons for delay/rejection of regulatory submissions and a way of evaluating which risks to accept and which to control during development. The aim of the workshop is to equip delegates with the necessary knowledge to take scientifically sound decisions during the development process, with the aim of reducing cost and timelines.
- Understand how to address the needs of a regulatory submission during the drug development process
- Appreciate the importance of controlling drug substance and excipient quality during development
- How to evaluate risks to bioequivalence based on biopharmaceutic and pharmacokinetic knowledge
- How to set drug product specifications at each phase of the project and support them with appropriately-validated analytical methods
- Understand options available to improve drug product shelf-life through choice of appropriate primary packaging
- Appreciate options for demonstrating bioequivalence, including biowaivers
Who Should Attend:
The workshop is aimed at employees of drug development companies who would like to gain an understanding of the drug development process, including professionals working in:
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Departments
- Analytical Development
- Formulation Development
- Production Departments
DAY 1 : (9 AM – 5 PM)
Registration: 8.30 AM – 9 AM
- Overview of ICH Q8 (Pharmaceutical Development)
- The biopharmaceutics classification system and drug pharmacokinetics
- Roles and responsibilities within the pharmaceutical development team
- Commercial and regulatory considerations
- Drug master files
- Excipient quality considerations
- Drug product specifications
- Compliance with regulatory expectations in relation to elemental impurities and residual solvents
- Quality target product profile, critical quality attributes and control strategy
- Managing risk in pharmaceutical development
- Regulatory submissions: the Common Technical Document
- Performance requirements of analytical methods
- Attributes of stability-indicating assay and impurities methods
- The dissolution method
- Discriminating potential
- Regulatory expectations for immediate, delayed and extended-release products
- Uniformity of dosage units
- Moisture: significance and measurement
- Assay methods for preservatives and anti-oxidants
- Microbiological methods and specifications
- Polymorphic and enantiomeric stability
- Phase-appropriate method validation
- Life-cycle management of analytical methods (ICH Q14)
Q&A and Networking: 4.30 PM – 5 PM
DAY 2 : (9 AM – 5 PM)
- Chemical compatibility
- Blending and granulation
- Compression and the effect of material properties
- Measuring the physical properties of tablets
- Capsule properties
- Scale-up and registration batch manufacture
- Process validation
Drug product stability evaluation
- Choice of primary pack (protection against moisture, oxygen and light)
- Early stage
- Drug product stress studies
- Prototype/feasibility stability
- Late stage
- Registration batch stability
- Temperature cycling and bulk hold studies
- In-use stability for multi-dose packs
- Clinical studies
- Biowaiver conditions (including new draft ICH guidance)
Q&A, Certification, Networking and Close: 4.30 PM – 5 PM
Dr. Mark Powell
He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.
Terms & Conditions to Register for the Seminar
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at email@example.com
Payment is required to be made at least 10 business days prior to the date of the conference.
To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.
Customer Support: +91-80-4170-0521
Attendance Confirmation and required documents:
After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.
If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.
We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.
Cancellation & Refund Policy:
Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.
On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
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If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.
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Mercure Hyderabad KCP, Banjara Hills
Hyderabad, TS, India | December 9 – 10, 2019