Pharma Regulatory Submissions Know how – Training Bundle

Pharma regulatory affairs professionals drive the regulatory submission preparation and management. Employers expect you to have all round knowledge and skills to develop high-quality regulatory submissions that stand the test of agencies and gain first-cycle approval that helps in bringing products to market quickly creating a competitive advantage.

The dossier must be compliant with the relevant regulations, loaded with right set of data and most importantly in the right format.

ComplianceOnline has engaged elite experts and ex-FDA officials to provide detailed knowledge in the regulatory submissions for you and your team through the following training bundle.

This bundle is ideal for both new and experienced regulatory affairs professionals to understand the regulatory interpretations, best practices in regulatory writing and other interactions with FDA for successfully steering the company in a compliant manner. The level of your knowhow can make the difference between reduced or enhanced waiting periods for life-enhancing medications, increase peak sales days, and simplify and streamline your organization's processes.

See what’s covered in the training bundle

An Introduction to the FDA New Drug Approval Process
Electronic Submissions to the FDA - eCTD Requirements
Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body
505(b)(2) NDAs
The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

An Introduction to the FDA New Drug Approval Process

Covers the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements.

Areas Covered in the Webinar:

• FDA's various NDA review and approval pathways.
• FDA's ANDA or Generic Drug review and approval process.
• The difference between a “full” NDA and a 505(b)(2) NDA and an ANDA.
• The various elements of a full NDA, 505(b)(2) NDA and ANDA.
• When and how often it is necessary to meet with FDA during the review and approval process.
• The costs involved with filing a drug application included required User Fees and options for obtaining Fee Waivers or Reductions.
• An introduction to the differences between Phase I, Phase II and Phase III clinical testing.
• An overview of FDA approval times and rates.
• Options for Marketing Exclusivity.
• Strategies for success and efficiency.

Electronic Submissions to the FDA - eCTD Requirements

Course highlights summary of eCTD requirements, format and content, how to prepare and file an IND application, how to do filing to an existing IND and best practices for IND submission.

Areas Covered in the Webinar:

• eCTD format and content
• eCTD applicable and not applicable types of submissions
• Summary of the requirements for electronic submissions
• Preparing and filing an electronic IND application
• Filing to an existing IND
• Good submission practices
• Common eCTD pitfalls

Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.

Areas Covered in the Webinar:

• Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations.
• Step-by-step analysis of how to present both good and poor data in a persuasive manner.
• How to train scientists and engineers to generate "good" data to support legal, regulatory and quality claims?
• Tips and secrets to framing an argument that makes even poor data look good.
• Examples of good writing that can be useful templates for training and skills development.
• What you should never say in a quality or regulatory document?

505(b)(2) NDAs

Learn which products qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) and the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.

Areas Covered in the Webinar:

• What is a 505(b)(2) NDA
• What products qualify for submission under 505(b)(2)
• Examples of data and information that may be referenced
• Requirements for studies to be conducted
• Submission content requirements
• Limitations to and benefits of a 505(b)(2)

The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND

This webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.

Areas Covered in the Webinar:

• US FDA and EU Agency Orientation / Structure.
• Start –Up and Conducting Clinical Trial Processes.
• Following Product Registration / Licensing Options.
• Company Strategy- Linking Clinical Trials & Marketing Authorization Applications.
• Balancing Strategy and Long Term Regulatory Cost & Maintenance.
• IMP Dossier & Comparisons of the US IND to the EU CTA Content.
• Scientific Advice: Member States vs. Pre-IND Meetings with U.S. FDA.
• Orphan Drugs: EU vs. US Treatment.
• GCP Compliance Inspections.
• Essentially Similar and Generic Products.
• Cross-Agency Interactions: Comparing U.S. FDA and EMA.
• Effective Interactions with the Global Regulatory Healthcare Authorities.
• Helpful Websites.

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

This course provides you with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics.

Areas Covered in the Webinar:

• Who really needs a DMF and why?
• The various types of DMFs - which is best for your products.
• The relationship between DMFs and drug and biologics applications.
• The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).
• Common DMF errors - how to avoid them.
• How to deal with deficiency letters and their origins.
• Effective change control strategies.
• Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.

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