BioPractice In-House Training Modules

BioPractice provides world class in house training to all the startups, mid size to top notch companies dealing in the FDA, EMA other regulated industry.we offer strong support to the companies on professional continuing education programs.

Our aim is to be a strong backend to the companies on the latest learnings and development through professional continuing education programs related to the regulatory, research and developement etc.

Medical Device

Provide assistance in preparation and/or review of device submissions including 510(k)s, IDEs, PreIDEs and other Presubmissions, PMAs, HDEs, 513gs and RFDs
Assist with the preparation for FDA Advisory Panel meetings
Experience with device and combination product development issues, including preclinical data requirements, clinical trial design, device regulatory strategy development, device testing design, advertising and promotion, and post-approval studies
Experience developing quality systems documentation, implementation of quality systems and training of regulatory staff as required for compliance with 21 CFR 820.
GxP Training and Audits: evaluation of vendors, facilities, clinical sites, processes, quality systems and due diligence
Pre-Approval (PAI) and Pre-Market Approval (PMA) inspections and pre-certification (ISO and CE marking) preparation
"Corrective And Preventive Action" CAPA program development and implementation
Provide Assistance in compliance issues such as Warning Letters, Complete Response Letters and Consent Decrees

Biosimilars

Biologics constitute a major share of expenditure in USA and internationally but prove sometimes unaffordable. In fact, there is a huge demand for lower cost biological drugs worldwide.
As the patent protection of many biopharmaceutical products expire biosimilar products are expected to have a large market size and high growth rate in the near future fueled by increasing establishment of regulatory pathway. However, there remain a large number of barriers, not least of which is the lack of guidance for the implementation of the biosimilars pathway in the US.

To overcome this hurdle US Pharma companies need to determine a route to launch or market their biopharmaceutical products by evaluating the lessons learnt from the biosimilar regulatory processes that are being laid down by the European Medicines Agency (EMA). Furthermore, this experience is a model to potential abbreviated development pathways of registering a "new generation" of protein and mAbs previously described “Biobetters“.

Understanding the role and workings of the 30 national regulators / Competent Authorities and the European Medicines Agency (EMA)
The EU national, mutual recognition, decentralized and centralized pathways to Approval
Comparing and contrasting European with FDA pathways to approvals
Background and history to EU centralized marketing authorization applications (MAAs) of biosimilars
Possible interpretations of the "Biological Price Competition and Innovation Act" of 2009 followed by the "Patient Protection and Affordable Care Act" of March 23, 2010 of the USA and future FDA biosimilar approval scenarios
EU eCTD dossier contents vs. US
The importance of the reference medicinal product
Comparability issues concerning chemistry, manufacturing and controls
WHO guidance in Biosimilars
EU biosimilar product specific biosimilar guidance's
Clinical bioequivalence, equivalence, interchangeability and substitution
The implementation of scientific and regulatory advice in Europe and America
Insights into the November 2010 monoclonal antibody EU biosimilars guidance
Insights into the November 2010 monoclonal antibody EU immunogenicity guidance
FDA perspectives on immunogenicity, and the European relevance

Pharmaceuticals

Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
Biosimilars – Understanding Regulatory Challenges
CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics
Hands on experience on FDA Regulatory Compliance for Drug and Biotech Products
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
European Regulatory Procedures - Hands on experience on EMA processes
European Union Regulatory Issues – New Product Development
GMPs for OTC
Good Clinical Practices (GCP) – Understanding and Implementing the Current Global Requirements
Good Laboratory Practices (GLP) for Pre-Clinical Testing
Good Manufacturing Practices (cGMP)

Clinical Development

Clinical Development Plans and Target Product Profiles, including: assisting with selection of --clinical indication, researching regulatory precedent, designing clinical (P1, P2, and P3) protocols
Prepare and/or Review clinical regulatory submissions including Pre-IND, IND, BLA/ NDA Clinical Sections, Package Inserts (labeling), Fast Track Applications, Orphan Drug Applications, and REMS
Prepare and/or Review Clinical Protocols, Clinical Study Reports, Investigator’s Brochures, Consent Forms, Case Report Forms and Study Manuals
Prepare clients to participate for regulatory meetings (FDA , EMA and other International regulatory bodies)
Provide GCP,GLP Training and Audits at Clinical Sites by former FDA field Investigators
Clinical consultants with extensive FDA/EMA and biopharmaceutical experience, often within the same product class (e.g., vaccines, monoclonal antibodies, small molecules, cell and gene therapy) and the same disease area (infectious disease, immunology, hematology, oncology, endocrine, dermatology etc.)