CMC Writing and
Submission Strategies:
A Global Regulatory
Approach
Quality Section
of Regulatory Applications
14 - 15 October, 2013
Course Topics Include:
• Drug Substance and Drug Product Data
in Clinical Trial and Marketing Applications
• Regulatory CMC Strategies for Global Filings
• Regulatory Compliance and Change
Management Considerations
• Case Studies
Parc Cientific de Barcelona
Baldiri Reixac, 10
08028 Barcelona - Spain
Who Should Attend
This course is intended for individuals responsible for
R&D/technical writing/quality management/original and
postapproval submissions in pharmaceutical companies,
especially those in:
•
•
•
•
•
•
• Explain special writing strategies for Quality By Design
marketing applications, Drug Master Files and “Most
of the World” registration dossiers
•Identify regulatory compliance issues in agency
inspections
Course Description
Regulatory Affairs
QA/QC
Process Chemistry
Analytical Chemistry
Preformulation and Formulation Development
Scale-up and Technology Transfer
Experience of one year or more in one of the above areas
is recommended to fully benefit from this course.
Learning Objectives
Upon completion of this course, you will be able to:
•Describe the regulatory review processes and health
authority expectations through product lifecycle
•Analyze and compile CMC data to support CTD clinical
trial applications, registration files and post approval
submissions in the US and Europe
This course will provide in-depth instruction on Chemistry,
Manufacturing and Controls (CMC) requirements and
review processes for clinical trial, registration and post
approval drug applications in the US, Europe and Japan.
Additional considerations and integrative approaches for
submissions in emerging markets (“Most of the World”
countries/regions) will be discussed.
Emphasis will be placed on current national and ICH
guidelines, and special considerations for biologics will
be discussed.
Development, manufacturing, analytical testing, controls
and stability issues will be presented for solids, parenterals
and other dosage forms.
Overviews of Quality By Design (QbD) submissions and
Drug Master Files will be presented.
Successful regulatory filing strategies and best practices
will be illustrated with examples and case studies.
Course Director
Cheenu Murti is currently Director of Global CMC Regulatory
Affairs at Merck & Co., Kenilworth, New Jersey. Prior to company
mergers, he worked in positions of increasing responsibility at
Schering-Plough and Organon, including three years at N.V.
Organon, Oss, The Netherlands. He has a B.Pharm. from
the University of Bombay, India, a Ph.D. in Pharmaceutical
Sciences from the University of Missouri and an MBA in General
Management from Rutgers University, New Jersey.
Over a professional career spanning more than 20 years,
Dr. Murti has worked in the analytics, preformulation and
formulation development, and technology transfer areas. Since
2000, he has been in regulatory affairs where he has led global
teams through the clinical trial application, product registration
and postapproval phases.
He also served as a member of the PhRMA eCTD working
group and Organon’s liaison with USP. He co-chaired regulatory
CMC teams on joint full development projects with Sanofi and
Pfizer, leading to successful registration outcomes. He has
interacted with health authorities in the US, Canada and Europe
and has developed global regulatory submission strategies and
written submissions for drugs belonging to different therapeutic
classes and dosage forms.
Dr. Murti has been an active member of several professional
associations over his career including AAPS, AAiPS, PDA, DIA
and RAPS and given invited presentations in the US and in Europe.
He co-teaches a graduate course in regulatory science at the
Philadelphia College of Pharmacy, University of the Sciences,
Philadelphia, Pennsylvania, where he is adjunct faculty.
Course offered by The Center For Professional Advancement
O U T L I N E
C O U R S E
First Day
Second Day
8:30-9:00: Registration
9:00-17:00
9:00-17:00
CTD Module 3 in Marketing Applications
Course Introduction/Review of Learning Objectives
• Rational writing for NDAs, MAAs, BLAs, ANDAs, etc.
• Agency review expectations and experiences
Regulatory Agencies and Processes
•
•
•
•
FDA, EMA and ICH organization and roles
Regulations/directives/guidelines for CMC
Marketing authorization procedures
Regulatory intelligence & agency interactions
The Common Technical Document (CTD)
• ICH M2 and M4 guidelines: writing for electronic
submissions
• Considerations for emerging market filings
Supporting Documents and Regulatory Approaches
• Drug Master Files
• GMP support documents (licenses, CEPs, etc.)
• Adventitious agent safety evaluation
CMC Content and Strategies
for Clinical Trial Applications
•
•
•
Regulatory and GMP considerations
for INDs/IMPDs/CTAs
Content issues for drugs and biologics
Globalization strategies
CTD Module 2.3 (Quality Overall Summary)
in Marketing Applications
Quality by Design Submissions and Special Cases
• ICH Q8 and Q11
• Combination product filings
• Special dosage forms
Agency Inspections and GMP
• Relating regulatory content to pre-approval inspections
• ICH Q9/Q10
Postapproval CMC Changes
• US and EU postapproval guidelines and filing strategies
• Biopharmaceutical guidelines and biowaivers
• Global file maintenance
Interactive Workshop: Case Studies/Special Topics
Assessment Opportunity
Approximately 15-minutes coffee breaks at 11:00 and at 15:45
and a one and a half-hour lunch break at 13:00 are planned for each day.
• “Real world” writing approaches
• Content harmonization challenges
Interactive Workshop: Case Studies/Special Topics
Assessment Opportunity
TUITION AND PAYMENT
Early registration:
(received before August 23th, 2013) - Euro 1400+VAT/1250+VAT (group discount*)
Regular registration:
(received after August 23th, 2013) - Euro 1600+VAT/1450+VAT (group discount*)
(Fee includes course materials, lunches and coffee breaks)
Participants are responsible for their own hotel reservations.
*Group discount is for two or more enrollments from the same company.
Payable by bank transfer upon issuing an invoice. Payment instructions will be provided upon registration.
Registration
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Cancellations received after September 23,
2013 will be invoiced completely. All cancellations
will be subject to Euro 200 processing fee.
Substitutions may be made at any time. Payment
is due once the participant receives an invoice.
Certificates will be issued to participants upon
completion of the course.
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PLEASE RETURN BY FAX OR E-MAIL
For Information please contact us at:
Office:+34 93 4487156
Cell: +34 691676055
Fax: +34 93 4037109
e-mail: info@sitec-pharmabio.com