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8-9 May 2018Novotel Dubai Al Barsha Hotel, Dubai, United Arab Emirates
Navigating CMC Requirements During Drug Development and Post-Approval
OVERVIEW
The competitive environment of pharmaceutical companies that are developing new drugs is pushing the experts to find new and creative ways to increase the acceleration process of the drug development. Focusing on clinical trial part, sometime, the CMC section is often not given the same attention as needed. The occurred CMC challenges can be faced with proper training and understanding of the different approaches from global to regional guidance.
This training will not only offer you the overview of the existing regulatory aspects of the CMC, but it will also give you a proper understanding on how to face the challenges during the drug development and its post-approval.
LEARNING OBJECTIVES
At the conclusion of this course, participants will be able to:• Understand the guidelines proposed by FDA/EMA/WHO and ICH• Learn the CTD structure and the alternative submission type for CMC documentation• Identify the differences between IND/IMPD requirements in EU and US• Assess the drug manufacturing requirements• Be prepared for inspections
Participants will complete a knowledge check at the end of the course to ensure learning objectives are attained.
KEY TOPICS
• Overview of Global development process and guidance• Drug substance requirements from manufacturing to preformulation studies and analytical
validation• Drug product specification and stability• Lifecycle management
WHO WILL ATTEND
• Quality assurance and compliance experts• CMC and manufacturing personnel• Regulatory affairs professionals
INSTRUCTOR
Per HelboeProfessorUniversity of CopenhagenDenmark
DAY 108:00 REGISTRATION
08:30 SESSION 1
OVERVIEW OF GLOBAL DRUG DEVELOPMENT PROCESS• Drug development process• Patent protection and data exclusivity• CMC aspects during drug development• Preformulation• IND/IMPD requirements• Submission phase• Life-cycle management
09:30 SESSION 2
OVERVIEW ON GLOBAL AND REGIONAL GUIDANCE• FDA and EU guidance• WHO recommendations• ICH structure and guideline development
10:30 COFFEE BREAK
11:00 SESSION 3
CMC DOCUMENTATION AND CTD• CTD Structure• CTD Modules 2 and 3• Alternative submission types for CMC documentation o DMF (US) o ASMF (EU) o CEP (Certificate of suitability) (EU) o WHO prequalification of APIs
12:00 LUNCH BREAK
13:00 SESSION 4
DRUG SUBSTANCE REQUIREMENTS• Manufacture of drug substance – including outsourced manufacturing• Drug substance characteristics and preformulation studies• Small molecules versus biologicals• Drug substance specification• Analytical validation• Impurities• The role of pharmacopoeial monographs
15:00 COFFEE BREAK
15:30 CASE STUDY #1
16:00 END OF DAY 1
DAY 208:30 SESSION 5
DRUG PRODUCT REQUIREMENTS• Pharmaceutical development including QbD (Quality by Design)• Manufacture of drug product• Excipients• Drug Product specification• Impurities/degradation products
10:00 COFFEE BREAK
10:30 SESSION 6
STABILITY• General aspects of Stability Testing• Relevant guidelines• Drug substance and product testing• Data evaluation and specifications• Climatic zones• In-use stability testing• On-going stability• Matrixing and Bracketing
12:00 LUNCH BREAK
13:00 SESSION 7
INSPECTIONS• Background for inspections• Drug substance and drug products, EU o Drug substance importation into the EU o CEPs role in relation to GMP and inspections• Drug substance and drug products, US• International collaboration o Bilateral and international agreements
14:00 COFFEE BREAK
14:30 SESSION 8
LIFECYCLE MANAGEMENT• Lifecycle management background• Variations - EU• Extensions and renewals - EU• FDA Concepts• ICH lifecycle management activities
16:00 CASE STUDY #2
16:30 QUESTIONS AND ANSWERS
17:00 END OF TRAINING COURSE
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of the DIA. Speakers and agenda are subject to change without notice. Recording during DIA sessions is strictly prohibited without prior written consent from DIA.
| Plan Your Team’s Professional Development
Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:• Focus• Flexibility• Convenience• Cost Effectiveness
For more information please contact [email protected].
| About DIADIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators, and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for exchange of knowledge and has the inter-disciplinary experience to prepare for future developments.
The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients.
DIA is an independent, non-profit organisation has its Global Center in Washington, DC, USA with the European office in Basel, Switzerland, and additional regional offices in Horsham, Pennsylvania, USA; Tokyo, Japan; Mumbai, India; and Beijing, China
| Training Course VenueNOVOTEL DUBAI AL BARSHA HOTELOpp Sharaf DG Metro StationSheikh Zayed Road Barsha 1POB 450011, DubaiUnited Arab EmiratesTel: +971 4 304 90 00Email: [email protected]
DIA has blocked a limited number of hotel rooms for the course participants from 7 to 9 May 2018 at the rate of AED 350.00 per superior single room per night including breakfast, 10% municipality fees and 10% service charges, excluding AED 15.00 Tourism fee and 5% VAT (applicable as of 1 January 2018).In order to book a hotel room, please contact the hotel directly and quote the booking reference “DIA”:Tel: +971 4 381 22 18Fax: +971 4 304 91 00Email: [email protected] room rate is available until 8 March 2018 or until the room block is sold-out, whichever comes first.
HOW TO GET THEREFrom Dubai Airport take the Red Metro line towards UAE Exchange and get off at Sharaf DG station. The hotel is located right next to the station.www.dubai-online.com/transport/metro/map
| Continuing EducationThe Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 11.5 credits.
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| Special Group DiscountBuy 3 and Get 1 Free!
All 4 individuals must register and prepay at the same time without exception. DIA will apply the value of the lowest applicable fee to this discounted registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.
Group registration is not available online and only available for the industry rate.
To take advantage of this offer, please print the registration form for each of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
For groups of 5 or more individuals, please contact [email protected] for a custom group rate.
REGISTRATION FORMNavigating CMC Requirements During Drug Development and Post-Approval # 185388-9 May 2018 | Novotel Dubai Al Barsha Hotel | Dubai, United Arab Emirates
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TERMS AND CONDITIONS
CANCELLATION POLICYAll cancellations must be made in writing and be received at the DIA office four weeks prior to the event start date. Cancellations are subject to an administrative fee:
• Industry (Member/Non-member) € 200.00 • Academia/Charitable/Government/Non-profit (Full-time) (Member/Non-member) € 100.00
If you do not cancel four weeks prior to the event start date and do not attend, you will be responsible for the full registration fee.DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled or postponed, DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.
TRANSFER POLICYYou may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute attendees will be responsible for the non-member fee, if applicable. Please notify the DIA office of
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PAYMENT METHODS
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REGISTRATION FEESRegistration fee includes refreshment breaks, lunches and electronic access to training course material. Please note that the full amount must be received by DIA by commencement of the course to get the electronic access to the material. Please check:
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Payment is due 30 days after registration and must be paid in full by commencement of the course.
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All non-members fees include a one year membership option. If you registered at one of the non-member rates noted above, you will automatically become a DIA member. Join DIA now to qualify to save on future events and to receive all the benefits of membership. Visit www.diaglobal.org and click on Membershipfor more details.
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The DIA Contact Centre Team will be pleased to assist you with your registration from Monday to Friday between 08:00 and 17:00 CET. Tel. :+41 61 225 51 51 Fax: +41 61 225 51 52
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