The following survey is designed to provide the ATMP Advisory Board Chairs information regarding the skills and aptitudes of potential candidates in order to assess their qualifications for membership in the advisory board.

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* 2. First Name

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* 3. Last Name

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* 4. Title

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* 5. Company

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* 6. Email Address

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* 8. Employment type

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* 9. PDA Membership (number of years)

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* 10. PDA Activities (mark all that you have participated in)

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* 11. Other Association Affiliation(s) and Activities

Topic Area Experience Self-Ranking
Please indicate your level of knowledge or experience in the topic listed below.
NOTE: the topic listed refers to general experience/proficiency (not necessarily ATMP) unless specifically stated.

The criteria for ranking High/Medium/Low is:

High (H) – Extensive experience/expertise based that could be used to lead efforts on a topic independently – high level of competency/proficiency in this area and recognized expert in this area inside/outside of PDA 

Medium (M) - Current or past experience/expertise providing an amount of competence to participate or contribute, but not sufficient to be an independent leader – solid level of competence/proficiency in this area 

Low (L) - Cursory or no experience/expertise in the topic – low level of competence/proficiency in the area and not able to contribute significantly to advancing this area

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* 12. Topic Area Experience Ranking

  H M L
mRNA and oligo-based ATMPs
Controls and qualification of raw materials and starting materials (scope of GMP)
Facilities design/qualification
Production equipment for ATMPs – automation, etc.
Microbial contamination control strategy and risk assessments for ATMPs
Drug product manufacture/ testing
Drug substance/starting material manufacturing
Stability studies and expiry date assignments
ATMP Shelf life assignment (for cryopreserved cell therapy products)
Reference standard qualification and lifecycle management
Quality standards for ATMP
Product and process comparability studies for ATMPs
Technology transfer
Partnering with CMOs
ATMP vein-to-vein quality oversight for autologous cell products (e.g., apheresis collection and product administration at clinics)
ATMP-specific bio/analytical method selection/development/qualification/validation/bridging (etc.)
Quality system adaptation (appropriate quality to oversee the real-time process)
Process Validation (Stages 1-3)
Process control strategy (CQA, CPP, KPP, etc.)
Supply chain for individualized ATMPs
Material and lot disposition
Trace-/trackability of material and product (COC/COI)
Data management (e-batch records, translational data, etc.)
Regulatory intelligence/surveillance
Marketing strategy development and execution
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