Webinar on Regulatory Outsourcing: ” To or Not To”

Regulatory Outsourcing To or Not To

To Outsource or Not to Outsource”, the question that many of the companies may be asking.

The webinar aims to compare and contrast the advantages & disadvantages of conducting Regulatory Affairs from both a Sponsor/Manufacturers’ Point of View and from a RA Vendor’s Perspective.

Some of the Topics Covered are:

Should you consider outsourcing or not
What to Outsource & what not to
Hybrid Models
Share Practical Experiences

Date & Time :

Date: Wednesday, 26th August 2015

Time: 4 – 5 PM CET | 11 AM – 12 PM EST

Cost : None

Speakers: Dr. Alan A. Chalmers

About Speaker:

Dr Alan A. Chalmers is a pharmacist with over 35 years’ industrial experience mainly in the field of pharmaceutical regulatory affairs.

A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialization in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation.
After a few years 1975-1978 as Pharmaceutical Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group), he joined Ciba-Geigy in DRA in 1978. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs with global regulatory responsibilities for both new products and product maintenance.

Dr. Chalmers has been a consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organizing Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia.

Contact:
For more information mailto: webinar@makrocare.com

About MakroCare:

It’s a journey of 15 years with clients from across the Globe providing a broad range of knowledge-based contract research and consulting services to the worldwide pharmaceutical, biotechnology, and medical device industries. MakroCare has successfully helped clients launch products or expand into newer regions. Services included Regulatory Strategy to getting product approvals globally to maintain compliance. By effectively “productizing” knowledge and experience in the form of Regulatory Affairs Center of Excellence (RACoE), MakroCare has helped clients either accelerate their projects or save costs. MakroCare has developed Multi-Dimensional Regulatory Service Accelerators (NAVAT) that is helping companies to accelerate their Global Submissions and receive faster Approvals. In addition, our functional services include CMC Authoring, global submission management, LCM, Labeling & affiliate support.

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Webinar on Unique Device Identification (UDI): What and How within overall Medical Device Value Chain.


Free Webinar on Unique Device Identification (UDI) – June 18th 2015.

Planning and Implementation of the Medical Device Regulation (UDI)

Step 1. Developing the UDI compliance plan

  • Brief senior management on project scope and provide resource requirements with cost
  • Receive senior management project approval
  • Build the right team members who are dedicated and have the right complement of product/process knowledge
  • Define clear roles, accountabilities and responsibilities
  • Understand the requirements of the Medical Device Regulation
  • Engage in an approach that will confirm assumptions early and allow for joint agreed adjustment to the plan
  • Evaluate the supply chain business processes
  • Produce gap assessment and generate gap findings and conclusions
  • Prepare for innovative and sustainable change to the go-forward environment – monitor publications
  • Plan and provide that product experts enable knowledge transfer
  • Develop a plan for Change Management

Step 2. Understanding the Machine Readable Technology

  • That number on the medical device, It’s not just a number….It means something
  • Standard product identifier
  • Reach out to the global community
  • Benefit to the medical community
  • Better traceability
  • Expedite recalls

Step 3. Change Management

  • Create compelling story or business case
  • Build a team who are fully committed to the change initiative
  • Create the vision
  • Communication, Communication, Communication
  • Start with “short term” wins

Step 4. Risk Assessment keeping the system agile for future changes

  • Proactively identify and manage risks
  • Assess Labeling changes – Global Packaging
  • Supply Chain continuity planning

Step 5. Implementation of UDI plan across the value chain

  • Review with project team key points of requirement
  • Identify the representative products for assessments
  • Build implementation road map, resourcing including cost
  • Identify low impact product device for implementation as pilot project
  • Present implementation recommendations and validate with stakeholders
  • Parallel process low impact product device
  • Evaluate and communicate results of “pilot” product

Step 6. Identifying the data sources for FDA reporting

  • Develop UDI data source map
  • Develop UDI database for FDA Reporting
  • Submit information to FDA which will be used to populate the Unique Device Identification Database (GUDID)

Register your seat at this webinar for FREE!

Who should participate?

* Compliance Quality Assurance
* Risk Management professionals
* Regulatory affairs professionals
* Exe. Mgmt. Business Owners
* Labeling professionals
* Post Market professionals
* Safety professionals
* International BD professionals
* Medical Device Manufacturers

Speaker: Jim Petragnani

Jim developed multiple solutions and systems while directing the business development function at GS1, and implemented technology, standards and systems around framework similar to UDI, for various industries like Defense, Aviation including Medtech. He was also instrumental in consulting Industry members to assist FDA in developing the UDI framework and regulation. Jim Brings extensive experience and understanding on information technology and supply chain systems development and implementation.

Limited Participants:
Maximum 100 only

Contact:
Send your information for registration to mailto: webinar@makrocare.com

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Medical Device Pathway in India

Medical device market in India.

India is one of the largest medical device markets in Asia and it is growing significantly. Medical device market in India is pegged at $6.3 billion in 2013 and growing annually at 10-12 percent. Most of it is dominated by imported products. According to a recent report by The Boston Consulting Group (BCG), around 70 per cent of the medical devices used in India are imported.

As per the risk-based classification of medical devices, Low risk devices to be marketed with self-certification and High risk devices to be marketed after obtaining conformity assessment. Currently, manufacturers of medical devices which require registration in India should supply evidence of marketing authorization in the US, Canada, Europe, Australia or Japan, plus proof of approval in their country of origin. Full technical documentation must be submitted for CDSCO approval. Additionally, each manufacturing facility must be registered.

MakroCare takes pleasure in presenting this Webinar. A better understanding of what are DCGI expectations for Medical Device entry, Pathway in India, Medical Device Design & Quality standards, Import License and requirements for medical device clinical trials, product registration and product life cycle management.

Key Topics:

  • Medical Device Market
  • Indian Regulation & Entry pathway
  • Medical device Classification in India
  • Product Registration & Import Requirements
  • Regulatory Timelines
  • Clinical Trial of Medical Devices in India

Register your seat at this webinar for FREE!

Who should participate?
Regulatory Professionals, Clinical Development teams, Clinical Operations, Medical Affairs, Medical device Manufacturers, Clinical Investigators, Clinical Monitors/CRAs, Project Managers and QA Professionals

Limited Participants:
Maximum 75 only

Speaker:

Ms. Parul Chansoria
Biomedical Engineer & RAC

Parul

 

 

 

Facilitator: 

Laxman Jakkala, PhD
Director QA&RA, MakroCare

Laxman

 

 

 

Date & Time :

Date: Wednesday, 10th December 2014

Time: 3:00 PM CET to 4:30 PM CET

Cost : None

Email: Send your information for registration to webinar@makrocare.com

For More Information Click Here

Posted in Clinical Development, Clinical Monitors/CRAs, Clinical Operations, Clinical Research - CPC & BPO, Medical Affairs - Scientific, Medical Device, Project Managers, QA Professionals, Regulatory Affairs, Regulatory Compliance, Regulatory Professionals, Regulatory Strategy, Regulatory Submissions, Regulatory Writing | Leave a comment

Webinar on Centralized Monitoring: A Smart & Cost Efficient Clinical Monitoring Approach (Part-II) : 6th October 2014; 11.00 – 12.00 hrs US EST

Pharmaceutical Regulatory Affairs

Part II: Practical Guidance on Adopting Centralized Monitoring Approach

Centralized Monitoring appears to be the most suitable approach available today to proactively identify risks to data quality, and patient safety, in a cost‐efficient manner. The right implementation of a centralized monitoring approach is essential in maximizing benefits with regard to higher quality of study conduct, reporting and better monitoring of patient safety with reduced number of on-site monitoring visits. The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place. Designing realistic, efficient monitoring plans with pre-defined risk indicators, thresholds with suggested action plan, training of resources, selection and validation of analytical tools are important aspects of adopting centralized monitoring.

After overwhelming response to the first webinar on Centralized Monitoring: Understanding process and concept, MakroCare takes pleasure in presenting Part II of this webinar. As the industry is moving forward with the process of standardization and optimization for centralized monitoring to create further efficiencies in clinical trial management and to enhance data quality, this webinar will provide further insight in adopting a successful Centralized Monitoring approach.

  • Monitoring plans encompassing centralised monitoring
  • Technology to support a centralised monitoring approach
  • Real case scenario on reporting of centralised monitoring activities
  • Guidance on the aspects of system validation necessary for effective centralised monitoring

Speakers:

Sue Fitzpatrick
Director of Redtree People and Independent Training Consultant
Former Head of Education and Training
The Institute of Clinical Research, UK

Sue_Fitzpatrick_1

Jane Tucker
Independent Risk Management Consultant and Trainer, UK

 Jane_Tucker

Speaker & Facilitator

Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA

Ashok_Ghone_3[1]

 Date & Time :

Date: Monday, 6th October 2014

Time: 11.00 – 12.00 hrs US EST / 16.00 -17.00 hrs UK (BST)

Cost : None

Click Here to Register for Webinar or sent an e-mail to webinar@makrocare.com

For More Information Click Here

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Webinar on “Centralized Monitoring: A Smart & Cost –Efficient Clinical Monitoring Approach” : 5th September 2014 ; 10.00 – 11.00 hrs US EST

Pharmaceutical Regulatory Affairs

Part I – Centralized Monitoring: Understanding Concept & Process

As the complexity of clinical trials has increased significantly in the last few years, it is becoming more challenging for drug development companies to manage the cost of clinical development. The clinical monitoring cost accounts for one third of the total clinical trial management budget. However, traditional ways of conducting frequent monitoring visits for example every 4‐6 weeks to investigational sites, and 100% source data verification, do not necessarily guarantee higher data quality, better patient safety, or identify the critical issues early on. Therefore, it is imperative to look into alternative and smarter ways to proactively identify risks to data quality, and patient safety, in a cost‐efficient manner. Of the innovative monitoring approaches available, centralized monitoring appears to be the most suitable approach to enhance data quality and ensure patient safety in a cost effective manner. The FDA guidance document specifically encourages use of centralized monitoring techniques for certain monitoring activities, in place of, or to complement, traditional monitoring practices. Considering the need of centralized monitoring for efficient clinical trial management, MakroCare has organized this webinar in two parts to provide more insights on the process and implementation of centralized monitoring.

Centralized Monitoring: Understanding Concept & Process

  • Centralized monitoring concept
  • Centralized monitoring -regulatory perspective
  • Centralized monitoring as part of RBM
  • Centralized monitoring to support late phase studies
  • Centralized monitoring models
  • Real case scenario on the benefit of a centralized monitoring approach

Speakers

Sue Fitzpatrick
Director of Redtree People and Independent Training Consultant
Former Head of Education and Training
The Institute of Clinical Research, UK

Sue_Fitzpatrick_1

Jane Tucker
Independent Risk Management Consultant and Trainer, UK

 Jane_Tucker

Speaker & Facilitator

Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA

Ashok_Ghone_3[1]

 Date & Time :
Date:
Friday, 5th September 2014
Time:
10.00 – 11.00 hrs US EST / 15.00 -16.00 hrs UK (BST)

Cost : None

Click Here to Register for Webinar or sent an e-mail to webinar@makrocare.com

For More Information Click Here

Part II: Adopting Centralized Monitoring Approach (on 6th October 2014; details will be shared later)

 

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Webinar on “Performing Root Cause Analysis in Risk-based Monitoring (RBM)”

Pharmaceutical Regulatory Affairs                                           

Risk assessment and risk management are the two important aspects of risk-based monitoring. RBM is all about taking holistic approach to assess all possible risks and then have a proper plan for risk management. Effective risk action planning involves effective root cause analysis (RCA) as part of risk mitigation. Therefore, it is necessary to identify thoroughly root causes and sources of all potential risks, as well as root causes of failed risk mitigation to improve action planning.  Effective RCA helps to build a robust action plan for mitigation of risks.

This session includes more than the tools common to RCA, but also the scientific concepts of root cause analysis applied directly to clinical quality risk management practices with an outcome of tools specific for application in risk-based monitoring.

 Key topics

  • How to integrate root cause analysis to risk-based monitoring
  • How to implement RCA processes that work with sponsors, sites and CROs
  • Interventions based on RCA, for risk diagnostic process, action planning and revisions

Speaker

Sandra “SAM” Sather, MS, BSN, CCRA, CCRC
VP, Clinical Pathways, LLC
North Carolina, USA

Sandra

Facilitator

Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA

Ashok Ghone

Date & Time:

Date: Thursday, 20 February, 2014

Timings:

USA:
08.00 -09.00 hrs  PST
11.00 – 12.00 hrs EST

CET (Central European Time):
17.00 – 18.00 hrs CET

Cost : None

 For more details sent an e-mail to webinar@makrocare.com

Click Here

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Webinar on “Use of Digital & Social Media in Patient Recruitment & Retention” : 27th August 2013; 14.00 – 15.00 hrs US EST

Drug Development & Commercialization Partner

Digital and social media offer powerful, cost-effective tools for patient recruitment and retention in clinical trials.  Until recently these efforts relied on more costly, less precise traditional media such as television, radio and print advertising.

Approximately 62% of the global population is now engaged in social media. The use of social and digital media has been growing drastically allowing patient recruitment efforts to better target the pool of potential clinical trial participants.   With the added availability of quality performance metrics related to rate and cost of clinical trials enrollment, social media and other digital strategies are bringing results. This webinar will cover the use of digital and social media for effective patient recruitment & retention as well as strategies for planning & tracking.

Key topics

  • Social media pages vs. social media ads vs. digital media
  • Considerations in planning your social/digital media recruitment campaign
  • Tracking return on your social/digital media recruitment campaign
  • Using social media for retention

Speakers:

Nariman Nasser, CCRP
Senior Director, Participant Recruitment & Study Management Services
Clinical & Translational Science Institute
University of California, San Francisco, USA

nariman

Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA

Ashok Ghone

Date & Tile:Date: Tuesday, 27th August 2013
Time: 14.00 – 15.00 hrs US EST / 11.00 -12.00 hrs US PST

Cost : None

Click Here to Register for Webinar or sent an e-mail to webinar@makrocare.com

For More Information Click Here

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